WPC 2 BJ Z urier#|Kx6X@KX@HP LaserJet IIISi PostScriptHPIIISI.PRSx  @hhhhdSX@Њ  2O_a #|ECourierCourier BoldtScriptHPIIISI.PRSx  @hhhhYjX@2dX EvCourierCourier BoldT?xxxx6X@KX@?xxxx `KXTR&HHH H6X@Kh@R&HHHH `Kh2 3'3'Standard'3'3StandardHPIIISI.PRSx   #H H@; @# hh 7 x  c  7 #(Dietary Fiber and Cardiovascular Disease 7h c ddx !hddxZrj | c   "DStudy"Study Design"sSubjects"4Methods"M$Results"_- Comments   Anderson et al., 1991 (Ref. 92).  Intervention, parallel, placebocontrolled, randomly assigned to treatment groups after 8 weeks of diet therapy on American Heart Association (AHA) Step 1 diet and stratification by gender and cholesterol level. Purpose of study: to compare hypocholesterolemic effects of two bulk laxatives relative to psyllium and placebo.  163 mild to moderately hypercholesterolemic males and females enrolled in study, 117 completed 8week diet therapy, and 105 completed the study protocol. Subjects, ages 30 to 70 years, were free living. (total serum cholesterol (TC) 200 to 300 mg/dL and body weight within 130% of ideal.  Subjects consumed AHA Step 1 diet for an 8week adaptation period followed by an 8week parallel treatment period. Four doses of test product were taken each day, including one before each meal. Diet monitored with 3day food records at 4week intervals. Step 1 diet: Energy from fat30 to 33%; protein17 to 18%; carbohydrate (CHO)46 to 51%; Cholesterol<300 mg/day. Bulk laxatives tested: g/day psyllium powder (PSY) 10.2 methylcellulose powder 6 or 10.2 (MC) calcium polycarbophil tablets (CP) 4 cellulose placebo (PLA) 4@   Average Diet During Test Period PSY MC CP PLA Energy, Cal 1755 1742 1833 1768 Fat, % of Cal 30 33 32 31 Protein, % Cal 17.6 18 17.5 16.7 CHO, % 49.8 46.1 47.4 50.9 Fiber, g Total 14.5 14.2 13 15.1 Soluble 4.6 4.4 4 4.7 CHOL, mg 225 219 213 190 Baseline Diet phase: TC 4.5%; LDL 4.7%; HDL 2.9%; TG 5.8% The difference in TC between the PSY group and the placebo is not significant (4.3% difference). Lipids ValuesDiet + Fiber Comparison to baseline PSY MC CP PLA TC, % 8.2* 5.3* 2 3.9 LDL, % 13.4* 7.8* 4.1 4.6 HDL, % 2.2 4.8* 4.8 0.1 LDL/HDL 10.8* 3.8 1.2 4 TG, % 12.4 8.2 10.9* 7.3 * Significant from baseline.x No weight change by more than 0.5% from baseline. Weights at baseline and final were not given. Compliance reported as good for all test groups.* Side effects reported were mostly gastrointestinal. Choice of cellulose as a placebo is questionable. Cellulose may actually have a cholesterol lowering effect. 2h и /TABLECONTINUED2 *No data on saturated fat x88   Bremer, J. M. et al., 1991 (Ref. 91). Intervention, randomized, singleblind, crossover, placebo controlled.h 12 hyperlipidemic men and women (TC 220 to 348 mg/dL), free living.h Subjects were stabilized on phase II AHA diet for 3 months prior to study. Base diet: fat 25 to 30% total energy; saturated fat <8%; polyunsaturated fatty acid (PUFA) 5 to 10%; monounsaturated fat >10%; cholesterol <250 mg/d; fiber >20 g/1,000 Calories. Twoweek runin with the addition of bread to the diet prior to test. Subjects randomized to oat or wheat group for 4 weeks, followed by 2week washout, then crossover to other diet. Bread added to diet in place of other CHO foods. Men consumed 10 to 12 slices bread/day; women consumed 6 slices. Dietary assessment by food records and bread charts. Oat bread Wheat bread Total fiber, g% 5.2 6.1 Insoluble Fiber, g% 4.0 5.2 Soluble Fiber, g% 1.2 0.9 Oat bran intake: 34.2 to 68.4 g/day Total dietary fiber intake: Oat period Wheat period 32.2 g 34.1 g At beginning of first study period, there was no significant difference between TC, LDL, and HDL between groups. At end of 4 weeks, no significant difference between lipid parameters. TC, mg/dL Week 0 Week 4 % change Oat bran 286 274 4.1 Wheat bran 297 286 3.9 LDL % change from baseline Oat bran 5.4 Wheat bran 6.8 HDL % change from baseline Oat bran +10.3 Wheat bran +8.7 Mean body weights did not change during the oat period but decreased significantly during the wheat period. There was no measure of dietary soluble fiber. Subjects increased consumption of PUFA and decreased intake of saturated fat (all NS) during test period. Investigators accounted for  in fat consumption as due to use of PUFA margarine with bread. Oat bran bread was no better than wheat bran bread on lowering serum CHOL when subjects were on AHA diet. Small sample size.     Leadbetter J. et al., 1991 (Ref. 83). Intervention, randomized, not blinded. 40 men and women, ages 25 to 64 (TC 250 to 348 mg/dL), freeliving. A fourbyfour Latin square design; Subjects added 0, 30, 60, and 90 g/day oat bran to their usual diet for 1 month intervals. No washout between periods. Oat bran provided in weighed sachets and detailed advice and recipes were provided. Fiveday food records were kept prior to study and singleday records were kept during study periods. Betaglucan content of oat bran was 3.7 to 4.2%.H Base diets (excluding oat bran): 0 g/d 30 g/d 60 g/d 90 g/d Cal. 1854 1947 2017 2017 % Fat 36.6 34.7 33.5 34.8 % CHO 45.3 48.2 50.2 48.6 % Sat Fat 13.5 13.0 13.4 14.0 Fiber, g 27 23 26 24 Starch, g 64 86 93 99 Results: No S effect of OB at any dose on TC or LDL; no doserelated trend and no correlation between bran dose and change in CHOL conc. Oat Bran Intake, g/day 0 30 60 90 TC, mg/dL 278 284 279 273 LDL, mmol/L 4.77 4.65 4.85 4.58 HDL, mmol/L 1.56 1.48 1.49 1.42  Authors state that OB used in this study may be lower in SF content than the OB used in studies showing  CH with OB supplementation. No dietary or body weight data.XxHH     Resnicow, K. et al., 1991 (Ref. 96). Health survey, not controlled. 31 Seventh Day Adventist, ages 5 to 46 years (9 children 5 to 17 yrs; 27 adults 19 to 46 yrs); mean serum CH 131.5 mg/dL; free living. Subjects chosen had not consumed food of animal origin (including meat, poultry, fish, eggs, milk or other dairy products) for at least 6 mo prior to study. Lipid levels were reported separately for children. There were no blood lipid values for omnivore controls, so derived these values from Lipid Research Clinics Population Studies Data Book for basis of comparing vegans and omnivore controls. Current food intake measured using a quantitative food frequency questionnaire based on weekly consumption and typical portion sizes. Fiber intake for vegans: 45 g/day, controls: 20.p  Results for adults only: vegans % observed expected   differ.* mean values, mg/dL TC 139 182 23 LDL 81 116 30 HDL 54 50 +8 *Statistical significantly not reported. Vegans had S lower daily intake of energy; % energy from fat (31% versus 38%), total fat, satuarted fat, Monounsaturated fatty acid, and CHOL; and protein; also S higher intake of fiber.p  There are multiple confounding factors not addressed in this survey. Exercise patters, lifestyles, and body weight are just a few examples. Soluble and insoluble fiber were not assessed. Foods consumed in greater frequency by vegans: almonds, cashews, and their nut butters, dried fruits, citrus fruits, soy milk and greens. These foods contributed almost 40% of daily energy (only 7% for controls).@ xHH    Spiller, G. A. et al., 1991 (Ref. 87). Intervention, randomized, cross over. 13 male and females, 62 + 3.0 years, TC 204 to 276 mg/dL, free living. Threeday food record kept during baseline period and during 3rd week of treatment. Each treatment dose was preweighed in pouches; 3week supply given to subjects at start of each test period. Both fiber were mixed with water or other fluid and consumed before each meal. Subjects remained on regular diets. Test periods: 21 days then crossover to other fiber for 21 days. Blood lipid values made on days 14 and 21 during treatment period and on days 14 and 16 after treatment stopped. Fiber sources: guar gum: 15 g/day providing 11 g/d dietary fiber and 10 g/d SF; oat fiber source: 77 g/d providing 11 g/d dietary fiber and 5 g/d SF, 3.3 g glucan.`   TC LDL HDL mg/dL Baseline 244 152 62 Guar at day 14 217 124 63 day 21 219* 126* 63 oat bran at day 14 235 142 62 day 21 236* 143* 62 * Significant from baseline. Guar: 11%  TC Oats: 6%  TC`  Study needs a control group. Changes in TC for both treatment groups took place within 14 days with no significant changes taking place between days 14 and 21. Limitations of study: Short test period. No washout between test periods. Baseline diets and dietary intake during treatment periods not reported; total dietary soluble fiber was not reported. Small sample size. No dietary data. No weight changes. Both guar and oat fibers consumed before mealsnot typical dietary intake.   Cara, L. et. al., 1991 (Ref. 84). Intervention. 10 men and women (8 women), 35 to 68 years, TC 254 to 367 mg/dL, 6 had mild to severe hypertriglyceridemia, free living.h Subjects consumed regular diet for one week as baseline period, followed by 4 weeks on 30 g wheat germ (2.9 g dietary fiber), then 4 weeks on regular diet with no supplementation. Base diet monitored by 7day food recall; 3day food recall during last week of test period. Base diet: pro. 14.4% energy; fat 35.9%, refined CHO 8.7%, complex CHO 41%, dietary fiber 13.6 g/d, alcohol 6 g/d.  Baseline Wheat Follow  Germ   up  TC, mg/dL 302 276* 284 LDL, mg/dL 191 189 195 HDL, mg/dL 41.5 47 50 * Significant from baseline TC after final 4 weeks with no wheat germ not significantly different from baseline.  No control. Small sample size, no reporting of dietary soluble fiber and saturated fat in diet during baseline and treatment periods. Authors speculate that the protein content of wheat germ (high in vegetable protein) could account for the results observed. No saturated fat data.xHH 8  Kawatra, A. et al., 1991 (Ref. 88). Intervention. 20 overweight men and women (bodyweight 10% higher than Standard Weight for Height of Life Insurance Company India), TC 172.5 to 277.5 mg/dL, free living.H Subjects added 15 g guar gum to normal diet for 6 weeks. 10 g of guar was consumed in form of salted biscuits and 5 g was mixed with flavored drink 10 to 15 minutes before main meal. 1/5 of normal diet was collected for 3days prior to start of test period and during the last week of the test period and analyzed for nutrient composition.8  Baseline Final % change TC, mg/dL 212 176 16.7* LDL, mg/dL 144 105 26.5* HDL, mg/dL 54.8 55.4 1.5 TC/HDL 3.9 3.2 13.7%* * significant.8 Total dietary fiber, dietary soluble fiber and saturated fat were not reported. No body weight data.8 p   Tinker, L. F. et al., 1991 (Ref. 89).( Intervention, randomized, cross over, Subjects acted as own controls. 41 men, ages 29 to 79, TC 201 to 290, free living. 6 had history of cardiovascular disease or CV surgery. Dietary records made from selfreported food records collected every other day for 2 weeks prior to test. Food records kept during test periods. Subjects consumed either grape juice (GJ) (360 mL/day) or 12 prunes (PR) (100 g/d) for 4 weeks, followed by crossover to other diet for additional 4 weeks. 100 g of prunes provides 6 to 7 g DF, of which approximately 60% is pectin. `  Base diet GJ diet PR diet Energy 2522 2572 2579 Pro, % 16 15 14 Fat, % 33 30 30 CHO, % 47 51 51 alcohol, % 4 4 5 CHOL, mg 276 255 277 DF, g 21 18 24 TC, mg/dL 226 230 226 LDL, mmol 3.89 4.09 3.92 HDL, mmol 1.30 1.27 1.26 There was no difference in TC levels between baseline diet & prune diet. Percent of energy from CHO on GF and PR diets increased, % fat and Pro decreased. Fiber intake increased on PR diet, decreased on GJ diet. Authors compared results of prune diet to grape juice noting that plasma cholesterol tended to be lower at the end of the prune period, although not statistically significant. xHHp   8 Karlander, S. et al., 1991 (Ref. 85). Intervention, controlled, randomized, cross over.h 13 men and women with NIDDM, mean TC 275 mg/dL, free living. 5 were on chronic treatment with betablockers and diuretics because of hypertension; 8 were only on diet treatment with sulfonylurea (SU).8 Study was divided into three 6week periods: a runin period and 2 study periods. Run in period: subjects given routine dietary counseling aimed at optimizing body weight and glucose control. Subjects then randomized to start fiberrich diet or continue with regular diet (control). After first test period, subjects switched to other diet. Medications were left unchanged. Diet history and weights were taken every 3rd week. Dietary advice: energy reduction for obese patientsCHO 55% energy, fat 30%, Pro 15%. Fiber: beet fiber20 g Fibrex/day (16 G DF) divided into thirds and taken with each meal. Diet history showed base diets: 44% energy as CHO, 40% fat, 16% Pro, mean DF in control diet and SUtx patients was 18 g/day. TDF during test period was 34 g/day.@  During runin period SU tx group had S loss in body mass index; no other weight loss occurred with either group during the test periods. Diet SU group group TC, mg/dL fiber 278 247* control 275 275 *Significant difference from SU control group.@  Cholesterol lowering (10%) only in patients treated with SU. Authors state that hypocholesterolemic effect of this magnitude appears to be common during fiber treatment of NIDDM. Authors also note that another study noted a similar effect of guar in insulintreated, but not SUtreated patients with NIDDM. They conclude that this suggests that a hypocholesterolemic effect of fiber in NIDDM patients is not linked to the type of treatment but may be explained by patient selection. Beet fiber had no effect on serum triglycerides or in glucose control in this study. No body weight data.xxHH    Israelsson, B. et al., undated (Ref. 86). h Intervention, placebo controlled, double blind, crossover.h 27 women, 55 to 56 years, TC 263 to 297 mg/dL, free living, selected from health screening program concerned with cardiovascular disease risk factors and the effects of high alcohol consumption.8 One month runin period on a moderate cholesterol, low fat diet with increased ratio of PUFA/SFA; followed by randomized assignment to intervention or placebo group for 1 month, then crossover. Placebo (bread crumbs or bread crumbs with bread) 30 g/day (3.5% fiber). Beet fiber (crumbs packed in 5 g portions or as bread with 3 g fiber/slice) 30 g/day. Beet fiber, Fibrex: SF 20%, IF 55%, TDF 75%. Diets provided between 1415 to 1494 Cal, 17 to 19.7% Pro, 27.6 to 26.9% fat. Total fiber 11.7 to 14.7 g/day (low fiber periods) and 33 to 34 g/day (high fiber periods).`  Compared to placebo, beet fiber reduced serum cholesterol S after 2 weeks. After 4 weeks, the difference was not significant. MEAN DIFFERENCE AFTER INTERVENTION (Fiber minus Placebo) mg/dL TC LDL HDL After 2 weeks 10.0* 8.5 3.1 w/ fiber After 4 weeks 7.7 11.6* +4.3 * Significant.`  Subjects made changes to their diet after the runin period by significantly decreasing their intake of alcohol. No report on the intake of dietary fat, especially the amounts of saturated and polyunsaturated fat consumed during test periods. Soluble fiber intake from diets not reported. Subjects on fiber consumed S higher energy from fat; placebo subjects consumed S more CHO. Limitations of study: short duration of study. No body weight data.   8  Kirsten, R. et al., 1989 (Ref. 97). Intervention, controlled. 13 men and women (7 with type IIa and 6 with type IIb hyperlipidemia), mean age 57.2 yrs, mean TC 286 mg/dL, free living.x Study was divided into three phases: a 30day pretreatment observation phase, 60 days of treatment, and 60 days of posttreatment observation. During test period subjects consumed 4 g of guar with water before each main meal (total of 12 g guar/day). Subjects instructed to avoid cholesterolrich foods during the study.X  PreTx  Tx  TC, mg/dL 286 251* LDL, mg/dL 213 186* HDL, mg/dL 48 44 *Significant compared to baseline Total cholesterol, LDL and HDL all returned to baseline 60 days after cessation of treatment.X Sample size was small. Dietary intakes were not reported. No control group. xxHH8 0    Jenkins, et al., unpublished (Ref. 94).h Intervention, randomized, crossover controlled feeding.h 11 normal subjects (6 men, 5 postmenopausal women) with mildly increased blood cholesterol. (mean = 242 mg/dL) (3 Type IIa, 7 Type IIb, 1 Type IV), free living.H After a 2month treatment with the AHA Step 2 diet, Ss randomized to a high soluble fiber diet (SF) or a high insoluble fiber (IF) diet for first test period. Test period 1 to 16 weeks; 2month washout on Step 2 diet only; crossover to test period 2 to 16 weeks. Step 2 diet: <20% kilocalories total fat, 20% Pro, 60% CHO, <50 mg cholesterol. The SF diet provided fiber from beans, peas, lentils, barley, oat bran, and psyllium enriched cereal. Ss received foods from the clinic, but lived at home. SF diet provided 16 g SF/d and 37.5 g/d IF. IF diet provided 12.8 g SF/d and 42.1 g/d IF. `  Both diets (SF and IF) reduced total and LDL cholesterol. SF diet reduced total cholesterol by 6.3% and LDL cholesterol by 8.6% compared to the IF diet. Insoluble Fiber Diet After 16 Baseline  Weeks TC, mg/dL 242 226 LDL,mg/dL 163 152 Soluble Fiber Diet TC, mg/dL 257 211* LDL, mg/dL 172 139* *Significantly lower compared to IF diet.   Well controlled study. The "soluble" and "insoluble" fiber diets differed by less than 4 g of SF, on average. The authors speculate that either current analytical methods may actually underestimate SF, or that IF may have some hypolipidemic effect from certain components such as lignin. They also note that some SF have no hypolipidemic effect (acacia, agar). Authors encourage consumption of fiber sources known to lower TC.  xHH0  x  Jenkins et al., unpublished (Ref. 93). Intervention, controlled feeding study with randomized, crossover design. 12 hyperlipidemic subjects (3 men, 9 postmenopausal women), ages 38 to 70, mean TC272 mg/dL, mean LDL 192 mg/dL.X Subjects consumed a Step 2 basal diet (see study above) for 2 months then randomized to receive either psyllium or wheat bran cereal. Test period 1 to 4 weeks; 2week washout on Step 2 diet; Test period 2 to 4 weeks. Patients received their food from the clinic, but lived at home during the study. The psyllium cereal diet provided 16.2 g/d of SF, while the wheat bran cereal diet provided 9.5 g/d SF. Subjects in the psyllium group ate 9.35 g of psyllium/day. The psyllium cereal diet significantly reduced TC and LDL cholesterol, while the wheat bran diet did not. PSY diet: Week 0 4 mg/dL Total CHOL 275 249* LDL 199 173* Control diet: Total CH 268 257 LDL 186 182 *Significant p < 0.05. In individuals with increased cholesterol and triglycerides in this study (Type IIb), the psyllium cereal diet did not reduce serum LDL cholesterol, while it was effective in Type IIa (elevated cholesterol without elevated triglycerides).`  Small sample size. Well controlled study. Psyllium containing cereal was shown to significantly reduce serum total and LDL cholesterol. The effect was independent of a low fat diet. No significant difference between groups for TC/HDL, LDL/HDL, apo B/A1. Preliminary results also suggest that psyllium cereals may not effectively lower LDL cholesterol in individuals with concomitantly elevated triglycerides (Type IIb). Subjects ate 9.35 g of psyllium per day (>3 ounces of cereal).  xHHx @   Anderson, unpublished (Ref. 95). Intervention, randomized, double blind, parallel. 44 men and women, mild to moderate hypercholesterolemic (TC 200 to 300 mg/dL), free living. Subjects (Ss) were followed for 7 weeks. Week 1 was baseline period when subjects consumed their usual diets. Then Ss randomized to receive psyllium (PSY) cereal or wheat bran cereal and instructed on Step 1 diet and asked to adhere to it for 6 weeks. Step 1 diet: 55% total energy as CHO; 15% as protein; 30% as fat, less than 10% as saturated fat, and less than 300 mg cholesterol/day. Ss returned to clinic after 2, 4, 5, and 6 weeks on cereal. 3day diet records were kept during week 3 of test period. Ss consumed 4 ounces of cereal (2 ounces in morning and 2 in evening). PSY cereal provided 11.6 g PSY, 24 g TDF, 12 g SF. Wheat cereal provided 20 g TDF and negligible SF.@  PSY group TC significantly  (8%) 251 to 230 mg/dL compared to baseline and significantly lower than wheat group. LDL  significantly (13%) in PSY group compared to baseline. No significant changes in wheat group.@  Average consumption of psyllium cereal was 3.7 ounces/day. @    Earll et al. unpublished (Ref. 90).0 Intervention.0 7 men and women, hyperlipidemic (TC 261 to 346 mg/dL), free living, ages 32 to 71, treated by physician for (average) 2.4 years for hyperlipidemia. Each subject served as own control. Ss were asked to take 24 g of fiber/day for 6 weeks and 48 g/day for 6 more weeks. At week 20 (8 weeks after test period ended), Ss had another blood lipid test. Ss instructed by dietitian on how to incorporate fiber into their diet and how to keep diet records. Diet records were kept for 3 days at the start, after 6 weeks, and again after 12 weeks. Corn fiber (milled and ground) provided 89% dietary fiber and less than 2% SF. Ss mixed the fiber with water. No indication when fiber was consumed during the day. Mean fiber consumption for first 6 weeks was 22.7 g/day; for second 6 weeks41 g/day. Two Ss stated that they could not consume 6 packets per day for 6 weeks so continued with 3 packets/day. Total cholesterol was significantly reduced on an average from 298 to 253 mg/dL, although much smaller changes were observed in two Ss and one subject had an increase in TC. TC returned to baseline after the 8week followup period when there was no intervention. There was no significant effect on HDL. LDL was not reported. Total dietary fiber, total SF, dietary saturated fat before, during, and after test period were not reported. Small number of subjects in this study. The serum cholesterol for all Ss except 1 remained above 200 mg with fiber intervention. No control group. No body weight data. xHH `  @  Wolever et al., unpublished (Ref. 101). Intervention, randomized, controlled, crossover.h 42 subjects (21 men, mean age 55 years; 21 women, mean age 58 years), 14 Ss were on lipid lowering drugs, 3 had type 2 diabetes.X Subjects were tested for two 2week periods separated by a 2week washout period. The base diet was an AHA Step 2 diet. During test period Ss asked to consume 2 servings of breakfast cereal daily: one in morning and one in evening. The test and control cereals were matched for energy and fed at a dose of 60 g/day. Psyllium (PSY) cereal provided 6.7 g/d of psyllium. After 2 weeks on PSY: Baseline Test TC, mg/dL 261 244* LDL, mg/dL 183 168* HDL, mm/L 1.14 1.10* * Significantly different from baseline. Subjects were consuming Step 2 diet which restricts fat to less than 20% of calories. Subjects consuming lipid lowering drugs had decreased TC of 6.1% and LDL of 4.7%, not statistically significant from diet alone group. The short test period of 2 weeks of this study limits the usefulness of the results.`    Wolever et al., unpublished (Ref. 102).P  Clinical trial to evaluate the effectiveness of psyllium taken in foods versus psyllium taken between meals.0 18 subjects (9 men and 9 women), mean age 54 years; 2 Ss were on lipid lowering drugs.0 Study design with three 2week test period separated by 2week washout periods. Ss all consumed AHA Step 2 diet prior to study. Three treatment periods: Ss provided with cereal were asked to consume one with breakfast and one with dinner; Ss asked to consume PSY cereal between meals; Ss asked to consume control breakfast cereal. PSY cereal provided 6.7 g TDF per day from psyllium and 23.1 g/d TDF from the cereal. The control cereal provided 23.2 g/d TDF. PSY with meals: Control PSY TC, mg/dL 259 237* LDL, mg/dL 185 164* PSY between meals: Control PSY TC, mg/dL 259 251 LDL, mg/dL 185 174 * Significantly different from control.  The 2 week period of this study limits the usefulness of the results. xHH  `  Spencer and Gee, unpublished (Ref. 109).h Intervention, crossover, blinded, placebo used.h 31 male, serum cholesterol between 200 to 270 mg/dL. h A 6week test period. Test subjects consumed 20 ounces of a fibersupplemented juice per day to the regular diet, which supplied 10 g of DF (70% soluble fiber, predominantly from gum arabic) Placebo group received 20 ounces per day of nonsupplemented apple juice. Ss were asked to maintain normal eating and lifestyle habits. With both ordered groups totaled, there is a significant decrease in serum total cholesterol and LDLcholesterol during the period of consumption of fiberenriched juice. The cholesterol intake was significantly higher in the juice only group. In the group, ordered plain juice, then fiberenriched juice, there is no change in total serum cholesterol followed by a significant decrease while on fiberenriched juice. In the group which was given fiberenriched juice first, there is a significant decrease while on the fiberenriched juice, followed by no increase while on plain juice. The authors attribute this to a carryover effect of the fiber, but this is difficult to say. xHH @   Neal and Balm, 1990 (Ref. 98).x Intervention, parallel, openlabel, clinical trial.h 59 subjects with total cholesterol between 215 and 396 mg/dL.h 29 subjects were assigned to dietary intervention only; 30 subjects were assigned to dietary and psyllium intervention. During the first 7 weeks, all subjects were to adapt to the AHA phase I diet. The subjects who were in the diet plus psyllium group were instructed to take psyllium in the form of Metamucil immediately after breakfast, and immediately after the evening meal for a 13week period. Dietary response period: During the first 7 weeks, men had significant lowering in their total serum cholesterol; women experienced very little change. After the treatment period, the PSY group had 5.5% additional decrease (significant) in TC compared to diet only group after the treatment period. Although there was a 5.1% in LDL in PSY group compared to control, this decrease was not significant. Total Cholesterol(mg/dL): Avg After Individual % diet Final Change Control 263 261 1.6 PSY 266 247 7.1* LDL Cholesterol (mg/dL): Control 182 176 3.5 PSY 190 172 8.6* *Significant from post diet. @  Although the compliance to the diet was checked, the breakdown of nutrients and amount of total soluble finer, total fat and saturated fat were not reported for each group. During the 7 weeks pretreatment period, results showed the women's TC did not respond to the AHA diet. Small weight loss in both groups.@  @   Uusitupa et al., 1989 (Ref. 100).0 Randomized, doubleblind parallel group.0 39 patients with NIDDM, mean age 58.6men and 61.4 yearswomen, mean TC 253 mg/dL; all 39 subjects were on drug treatment for diabetes, 15 were on antihypertensives, 7 Ss were on drug treatment for coronary heart disease, and 6 Ss were on drug treatment for both hypertension and coronary heart disease, freeliving. Ss were randomly assigned to test or control groups. Group A: Received 5 g guar gum three times per day before meals. Group B: received 5 g wheat flour three times per day before meals. After 3 months, group B switched to guar gum for the remaining 10 months of the study, and group A continued on guar. Ss advised to lower fat calories to 35% and increase carbohydrates to 50% of calories. Serum total cholesterol (mg/dL) runin 3 mo 12 mo A: 253 220 237 B: 253 242 233 There is a significant difference between the guar gum group and the control at 3 months. Significant weight loss occurred, but in both the control and treatment groups to a similar degree. Authors question compliance of Ss during months 4 to 12 because serum cholesterol increased in both groups. Group B showed highest serum cholesterol at month 11 (242 mg/dL). Diets during the test period were not reported. Total soluble fiber, total fat, and saturated fat were not reported. xHH@  0  @  O'Connor et al., in press B302 (Ref. 103).h Multicenter (7), doubleblind, randomized, parallel group, placebo controlled trial.X Males and females (169 randomized, 135 completed study), between the ages of 18 and 70 years with a diagnosis of mild to moderate primary hypercholesterolemia.H Step one diet for 9 weeks; 15week test period. Five Fiber Supplement (FFS) packet consists of 7.5 g SF (guar and pectin) and 2.5 g of IF. Placebo packet consists to 5.2 g of IF, no soluble fiber. During Week 1 of supplementation, Ss took 1 packet FFS per day, before dinner. During Week 2, they alternated days between one packet per day before dinner, and two packets per day, one before breakfast and one before dinner. During weeks 3 to 15, Ss took two packets of FFS per day, one before breakfast and one before dinner. Ss assigned to the two packet (26.4 g) group received FFS for all doses during Week 1 through Week 15. Ss who were assigned to the placebo group received placebo treatment for all doses during weeks 1 to 15.0  Percent change in fiber from baseline minus % change in placebo from baseline: Week TC  LDLC 3 9.0 12.7 6 7.8 10.3 9 8.7 11.8 12 6.2 10.3 15 6.8 10.2 All values are significant.0  Tightlycontrolled trial. Dietary factors wellcontrolled; all major nutrients kept constant except for fiber.XxHH0  h  O'Connor et al., in press B301 (Ref. 103).h Multicenter (4) doubleblind, randomized, parallel group, placebo controlled trial.X Males and females (161 randomized, 127 completed study), between the ages of 18 and 70 years with a diagnosis of mild to moderate primary hypercholesterolemia.H Step 1 diet for 9 weeks; 15week test period. Five Fiber Supplement consists of 7.5 g SF (guar and pectin) and 2.5 g of IF. Placebo consists to 5.2 g of IF, no soluble fiber. During Week 1 of supplementation, subjects took one packet of treatment per day, before dinner. During Week 2, they alternated days between one packet of treatment per day before dinner, and two packets of treatment per day, one before breakfast and one before dinner. During weeks 3 to 15, Ss took two packets of treatment per day, one before breakfast and one before dinner. Ss who were assigned to the one packet (13.2 g) of Five Fiber Supplement group received active treatment with the dose before dinner each day. The dose before breakfast during Week 2 (as required) and during Week 3 through Week 15 was placebo. Ss who were assigned to the two packet (26.4 g) group received active treatment for all doses during Week 1 through Week 15. Ss who were assigned to the placebo group received placebo treatment for all doses during weeks 1 to 15.h# Percent change from baseline in "Relative Efficacy" over time (relative to placebo). 1 Packet 2 Packets  Supplement Supplement Week  LDLC   LDLC 3Xz"z"I©7.6X$$NX*'*'S©12.0H+*' 6Xz"z"I©9.3X$$NX*'*'S©13.8H+*' 9Xz"z"I©4.5X$$NX*'*'S 7.5H+*' 12Xz"z"I©4.2X$$NX*'*'S 8.6H+*' 15Xz"z"I©5.9X$$NX*'*'S 7.9H+*' All values are significant for the twopacket group. Week  TC   TC  3Xz"z"I©5.2*X$$N 6.9*H+$ 6 Xz"z"I©5.0*X$$N 8.8*H+$ 9Xz"z"I©2.4X$$N 4.3*H+$ 12Xz"z"I©2.2X$$N 4.7*H+$ 15Xz"z"I©3.6*X$$N 5.3*H+$ * Significant difference.h# Wellcontrolled, freeliving, trial. Dietary factors wellcontrolled. All major nutrients kept constant except for fiber. A doseresponse was not statistically demonstrated between placebo, onepacket dosage and twopacket dosage.h   O'Connor et al., in press (Study B301 extension) (Ref. 103).H An openlabel study of the safety and efficacy of Five Fiber Supplement administered twice a day in conjunction with a low fat diet for 36 weeks.( Patients who completed 15 weeks of treatment with either one packet of Five Fiber Supplement per day, two packets of Five Fiber Supplement per day or placebo were eligible to continue therapy with two packets of Five Fiber Supplement per day for an additional 36week period. 102 entered and 59 completed the 36 additional weeks. During this openlabel extension, patients were continued on their Step 1 Diet. During the first week of the extension, patients took one packet of treatment per day (before dinner). Thereafter, during weeks 17 to 51, patients took two packets of treatment per day (one before breakfast and one before dinner). During the 36week extension of the trial, total Cholesterol was maintained at 5.3% (Significant) and LDLcholesterol at 8.4% (Significant) lower than baseline. This extension to the above study was not blinded by definition. The study was wellcontrolled for dietary factors and other major confounders.xHH   h Whyte et al., 1992 (Ref. 104). Intervention, randomized with crossover. 23 men, mean age 45 years, mild hypercholesterolemia (TC 209 to 259 mg/dL), free living.  Subjects were randomly assigned to either the wheat cereal group or the oat cereal group after a 3week baseline diet. During baseline period, all Ss consumed wheat cereal. Preweighed packages of cereal were provided: 54 g of wheat bran per day; 123 g oat bran per day. Base diet was typical Australian diet with approximately 30 to 34% of calories as fat. Ss instructed on how to keep dietary records, measure and restrict fiber (so all Ss would have approximately same total fiber intake of less than 30 g/d. Each fiber cereal (2 servings/day) was consumed for 4 weeks followed by crossover to other fiber cereal for an additional 4 weeks. Oat cereal: 10.3 g/d SF Wheat cereal: 3.4 g/d SF All diets: TDF approximately 27 g/d. Oat diets provided 71 g/d starch; wheat diets provided 42 g/d starch.  Data analysis showed no effect of treatment order. Base mg/dL line Oat Wheat TC 226 218* 228 LDL 159 150* 159 * Significantly compared to both baseline and wheat period.  Consumption of total fat and saturated fat during both test periods was about the same (35.5 g fat/1,000 kilocalories and 12.7 to 13 g saturated fat/1000 kilocalories). Short test period. No dietary cholesterol intake data.     Niemi et al., 1988 (Ref. 99).  Doubleblind, crossover trial with placebo.  22 subjects: 16 women, 6 men; with poorly controlled type 2 diabetes. Ages 40 to 76. Mean serum cholesterol 235 mg/dL and 255 mg/dL. 19 subjects on medication. The study consisted of two 12week treatment periods separated by 4week washout period. Eleven patients, selected at random, started with microcrystalline cellulose during the first 12week treatment phase followed by treatment with guar gum in the second 12week period. In the other 11 subjects, the sequence was reversed. Both types of fiber were taken with meals three times daily. The initial dose was 5 g/day, which was increased up to 15 g/day during the 2week period at the beginning of each treatment phase. X The pooled data show that serum cholesterol was significantly lower after 12 weeks on guar gum, but no significant change was found after cellulose. Serum cholesterol (mg/dL) Time Cellulose Guar Start 235 255 12 weeks 240 228* *Significant from start.X Although patients were advised to keep to their normal diet, no measurements of diet (total soluble fiber, total fat and saturated fat, etc.) were discussed to verify this. Only the pooled data was reported. It would be helpful to examine the response of each group separately. Is cellulose an appropriate control?(xHH     Cerda et al., 1988 (Ref. 105). Intervention, doubleblind, crossover with placebo.h 27 subjects: 9 men, 18 women, ages 27 to 69 years. Mean serum cholesterol 275 mg/dL (range of 208 to 420 mg/dL), free living.X A 16week study: 4week baseline, 4 weeks on placebo or pectin, 4week washout, then crossover to 4 week on placebo or pectin tablets. Ss consumed normal diets but consumed 27 tablets (9 at each main meal) daily during test periods. Dietary records were kept during weeks 1, 7, and 16. Each Ss served as own control. Grapefruit Pectin: 15 g/day Placebo (flour): 15 g/day.(  Baseline Pectin Placebo mg/dL TC 275 254* 275 LDL 195 174 191 HDL 41.6 41.1 41.5 *Significant from baseline and placebo. ( Authors reported good compliance to tablet consumption. The subjects dietary intake of calories, total fat, saturated fat, cholesterol, and soluble fiber were not reported. Short test period. No body weight data.xHH   Haskell et al., 1992 (Ref. 106). Intervention, randomized, doubleblind, placebocontrolled trials.h Total cholesterol range for all studies: 200 to 280 mg/dL Study (S) 1: 58 men and women, mean age 57 yrs. S 2: 40 men and women, mean age 56.4 yrs S 3: 16 men and women, mean age 52.5 yrs S 4: 49 men and women, mean age 56.3 yrs. All free living subjects. After baseline period Ss randomly assigned to one of 4 studies: S 1: 12week test. Evaluated CHlowering properties of mixed SF with 56% from acacia gum. Fiber product: powder mixture of acacia gum (9.7 g), psyllium (4.9 g) and guar gum (2.6 g) for a total of 17.2 g/day divided into 3 servings/day. All placebos consisted of 15 g of fructose. S 2: 4week test. 15 g/day acacia gum powder divided into 3 servings/day. S 3: 8week crossover using guar as control. Test fiber mixture: pectin (3.9 g), psyllium (6.3 g), guar (3.3 g), and locust bean gum (1.5 g) for total of 15 g/day SF given in 3 servings per day; guar control: 10 g guar and 1 g pectin for total of 11 g/day given in 3 servings/day. S 4: 4 weeks. A doseresponse study with SF test mixture used in S 3. Mixtures tested: 1 svg/d 2 svg/d 3 svg/d pectin, g 1.3 2.6 3.9 psyllium, g 2.1 4.2 6.3 guar, g 1.1 2.2 3.3 locust bean, g 0.5  1   1.5 Total g/day 5 10 15  S 1: There were no statistically significant changes from baseline to 6 or 12 weeks within or between groups. S 2: Baseline 4 weeks % change* TC mg/dL placebo 264 269 1.9 acacia 266 265 0.4 LDL placebo 200 206 3.3 acacia 194 195 0.0 HDL placebo 55 52 5.4 acacia 60 58 3.9 * not statistically significant from baseline. S 3: Baseline 4 weeks % change TC guar 249 225* 9.7 fiber mix. 249 230* 8.3 LDL guar 184 163* 13.6 fiber mix. 184 166* 12.4 HDL guar 54 50** 6.5 fiber mix. 54 51** 5.9 * Significant from baseline p<0.01 ** Significant from baseline p<0.05. S 4: Baseline 4 weeks % change TC placebo 261 262 0.3 5 g/d 255 242 5.2 10 g/d 259 247 4.9 15 g/d 275 242* 12.2 LDL placebo 184 186 0.8 5 g/d 186 176 5.6 10 g/d 187 174 6.8 15 g/d 211 179* 14.9 HDL placebo 67 62 6.4 5 g/d 57 54 4.1 10 g/d 61 62 1.9 15 g/d 53 48 9.4  R& * Significant from placebo .. Subjects' diets were not reported. Short test periods.xxHH    Nervi et al., 1989 (Ref. 107). Purpose of study was to evaluate hypothesis that legumes may be a dietary risk factor for cholesterol gallstone formation in Chileans. Nonblinded crossover intervention study.  20 young Chilean men, ages 18 to 22 years, mean TC 162 mg/dL. Subjects received a control diet for 25 to 30 days. Food preparation and intakes were controlled by nutritionists. Diets eaten for 6 days a week; Ss were allowed free food intake on Sunday. Test period was 30 to 35 days on a legume diet: beans 4 days, peas 2 days, lentils 1 day. Ss received 120 g dry legumes each day. Control and test diets were matched for calories, protein, fat, fiber and cholesterol intakes. Control Legume  Diet   Diet  Energy, Cal 3219 3219 % of Calories Protein 14 14 Carbohydrate 54 53 Fat 32 33 Cholesterol, mg 300 302 Total Fiber, g 12.4 12.5   Serum cholesterol (mg/dL)  Control diet   Legume diet  162 143 Difference is significant (p<.001).  Short test period. Authors reference a study that indicates that epidemiological studies have demonstrated increased prevalence of gallstones in men ingesting a diet that lowers serum cholesterol. No saturated fat intake data. No body weight data, low baseline serum cholesterol.  0   Unpublished study submitted with comments (Ref. 108).@  Doubleblind double crossover intervention.@  23 healthy men, Age > 18 years, TC > 240 (exact ages and total cholesterol not reported), free living.  Baseline period: 4 weeks Step I diet. Subjects randomly assigned to either psylliumwheat branpsyllium (n=12) or wheat branpsylliumwheat bran (n=11) for 8, 5 and 5 weeks respectively on each regimen (18 weeks total). Subjects were provided with boxes of cereal and instructed to eat 2 ounces of the study cereal in the morning and one ounce in the evening. The psyllium cereal had a total of 5 g of soluble fiber and 7.4 g of total dietary fiber per ounce. The wheat bran cereal had 1 g of soluble fiber and 5 g of total dietary fiber per ounce. Relative percentages of protein, fat, sugar and starch in the two products were reported to be similar. Effect of Psyllium versus Wheat Bran Cereal (in mg/dL) PSY WHEATBRAN Difference TC 225 235 4.3% * LDL 148 157 6.1% * HDL 46 45 * Significantly different p<.0001. It is difficult to evaluate the results of the study because the authors do not report the initial cholesterol values of either group, instead relying on differences between the groups' average cholesterol values. It is important to review the effect of the diet order, to observe any changes in going from one test product to the other, and note any temporal trends in rising or falling of cholesterol levels on each diet. No dietary data.xHH0      Anderson et al., 1984 (Ref. 110). Metabolic ward, study for 21 days with random allocation to groups. 10 male subjects age 46 to 66 with initial serum cholesterol > 260 mg/dL. All subjects received the control diet for 7 days, and then were placed on a test diet for 21 days. Control diets provided 19% of energy as protein, 43% as CHO, 38% as fat 20 g plant fiber, and 6 g soluble fiber per day. The oatbran diet provided 100 g of oat bran per day served as a bowl of hot cereal and five oat bran muffins per day. This supplied approximately 48 g total plant fiber and 18 g soluble fiber per day. The bean diet containing 100 g of dried beans per day provided the same amount of total plant fiber and soluble fiber as did the oatbarn diet. After controlled trial ended, subjects were given highfiber maintenance diets to follow for an additional 24 weeks; four of the subjects were followed for a total of 99 weeks.  Mean serum cholesterol values of oat and bean groups: (values in mg/dl). Xz"z"IX$$NTC LDL HDLH+$ Xz"z"IWeekH+z" Xz"z"I1X$$N294 216 37.2H+$ Xz"z"I4X$$N226 167 29.8H+$ Xz"z"I7X$$N233 169 31.4H+$ Xz"z"I10X$$N234 164 33.9H+$ Xz"z"I16X$$N232 164 33.9H+$ Xz"z"I24X$$N218 164 35.2H+$ *Note: All values are significantly lower when compared to week 1. After 99 weeks of followup (freeliving on highfiber maintenance diets), serum chol values were 26% (p<.001) below initial values at 24 week and 23% lower (p<.003) at 99 weeks.  Small sample size. Significant weight loss during test period; no significant weight loss during control period. Short period. No control.xHH    Fukagawa et al., 1990 (Ref. 114). Metabolic ward study; clinical trial, nonblinded, no placebo. Young men only ate their meals on the metabolic ward. The older group were admitted to the ward.8 Six healthy male students, age 18 to 24 (TC 200 mg/dL) and six healthy older men and women, age 67 to 86 (TC 238 mg/dL).8 The subjects were placed on a high fiber diet for a period of 21 to 28 days after consuming their usual ad libitum diet. High fiber diet: 68% of energy from CHOs, fat intake of 14%, protein of 18%; 33 g per 100 kilocalories of fiber. Plant fiber was provided by whole grain or grain cereals and breads(40%), vegetables such as beans, corn, or peas (20%), other vegetables (31%), and fruits (9%). Soluble fiber/day X1 Reg. Diet High Fiber J younger grouphh6 3.5 gX; 23.6 gJ older grouphh6 3.7 gX; 17.1 gJ Ad libitum diet assessed by dietary recall.p  Serum cholesterol in young and old subjects before and after 4 weeks of a high fiber diet: Xz"z"IBeforeX$$N AfterH+$ mg/dL BothXz"z"I 219X$$N 170 22%*H+$ (n=12) YoungXz"z"I 200X$$N 147 26%*H+$ (n=6) OldXz"z"I 238X$$N 193 45%*H+$ (n=6) *All "after" values are significantly lower than corresponding "before" values.p  Small sample size. There was no control group, fat was not controlled. The ad libitum diet was significantly higher in fat (37 to 42% versus 14% of calories), saturated fat (15 to 17% versus 3% of calories), and cholesterol (720 to 755 versus 90 to 134 mg/d) than the test diet. Ad libitum diet relied on dietary history alone. It should be noted that the objective of this study was to examine the effects of a high fiber diet on insulin sensitivity; the cholesterol findings were secondary. No body weight data.   Turnbull and Leeds, 1987 (Ref. 111). Clinical study, randomly allocated, crossover. 9 men, 8 women, age 23 to 59, initial serum cholesterol level of at least 232 mg/dL, free living. Subjects were placed on a onemonth runin period when they followed a lowfat diet (< 35% of calories from fat). Subjects were then randomly allocated to 1 month of an oat diet (50 g oats each day at breakfast and 100 g oats as biscuits or a wheat diet (37 g wheat biscuits each day at breakfast and 100 g wheat as biscuits. At the end of the month, subjects switched diets. Oat products provided 5.4 g SF/day. Wheat products provided 3.1 g SF/day.( Values for cholesterol before and after intervention: Sig Initial Final Change? mg/dL Oat period Total chol$$N232X*'*'S220X))XYH+) LDLchol$$N167X*'*'S143X))XYH+) HDLchol $$N 46X*'*'S 54X))XNSH+) Wheat period Total chol$$N228X*'*'S232X))XNSH+) LDLchol$$N159X*'*'S163X))XNSH+) HDLchol $$N 50X*'*'S 50X))XNSH+) Fat intake is higher during oat period (this does not invalidate cholesterollowering effect of oats). No saturated fat or cholesterol intake data.xHH   Walsh et al., 1983 (Ref. 117). Clinical trial, doubleblind, randomlyassigned, with placebo.h 20 women, (ages not given), obese (20% or more over ideal weight), mean serum cholesterol 198 mg/dL. The trail was of 8week duration. The glucomannan group (GM) took two capsules of a supplement containing 500 mg of purified glucomannan, three times per day, with 8 ounces of water, 1 hour before each meal. The placebo group (PG) took two capsules containing 500 mg starch under the same conditions. All patients were instructed not to deviate from their previouslyestablished eating and exercise patterns. Changes in weight and cholesterol Weight*'*' CholH+*' Xz"z"u Change ChangeH+z" Xz"z"u  (lbs)*'*'  (mg/dl)H+*' Week 4 8 4 8 GM 4.9* 5.5* 20.9* 21.7* Xz"z"uX$$}H+$ PG 0.4 1.5 5.9 4.7 Difference between groups. 7.0 lbs$$} 26.2H+$ * Significant difference between groups.  Because weight loss and cholesterollowering are closely correlated, it is not possible to conclude that the cholesterollowering effect is an independent result of glucomannan supplementation. `   Anderson et al., 1992 (Ref. 118).  Intervention, randomized, doubleblind, parallel design.p  44 men and women, ages 25 to 70, total cholesterol 199 to 300 mg/dL, 80 to 130% of desirable body weight, free living.`  Oneweek baseline periodSs consumed usual diet then randomized to receive psylliumflake or wheatbranflake cereal (control) for 6 weeks. Ss also instructed on step 1 diet and asked to adhere to this diet for 6 weeks. Wheat cereal: 28.4 g serving with 5 g total DF, negligible SF. PSY cereal: 28.4 g serving with 6 g total DF, 2.9 g PSY, 3 g SF. Ss were instructed to consume one serving of cereal the first day and add 28.4 g additional daily until a maximum of 114 g/day was reached. 114 g of PSY cereal would provide 24 g total DF, 11.6 g PSY, 12 g SF. Ss completed 3day diet record during week 5 of treatment period. h  Base Diets Wheat bran PSY Baseline Final Baseline Final Energy 1786 1899 1821 1723 (Cal) Fat 30.7 24.3 32.2 22.9 (% energy) SF, g 5.6 5.9 6.1 15.1* *Significant difference from wheat group. Serum cholesterol, mg/dL TC 254 254 252 230+ LDL 174 174 170.5 149+ +Significant difference from baseline. Change in PSY group significantly different from change in wheat group.h Authors reported slight but significant decreases in body weight in both groups across time. However, there was no significant difference in weight loss between groups. 0xHH`  P   Braaten et al., unpublished (Ref. 119). Intervention, randomized. 21 men and women, ages 43 to 64, hypercholesterolemic (mean serum cholesterol 255 mg/dL), free living.X Subjects consumed usual diets with the fat content adjusted to be at least 20% and preferably more than 25% of their daily caloric content. Threeday food dairy was used to record their diets before and during each treatment period. Instant soluble oat gum (3.6 g, 80% glucan) or placebo (maltodextrin) was mixed with noncarbonated diet fruit drink (250 mL) and consumed during each of the two main meals of the day for each 4week period. There was a 2week stabilization period prior to treatment, a 3week washout period between treatments, and a 3week washout period for the group on oat gum. Dietary fat intake ranged from 30% to 31% of energy, total caloric intake was 2161 calories (stabilization period), 2069 calories (gum period), 1988 calories (washout), and 2077 calories (placebo period). Total Cholesterol Initial Final mg/dL Placebo 255 255 Oat gum 262 238* *Significantly different from baseline and placebo. LDLCholesterol mg/dL Placebo 174 176 Oat gum 180 154 During washout following oat gum treatment serum cholesterol increased from 238 to 258 mg/dL.P  Total dietary soluble fiber, saturated fat and cholesterol intakes was not reported. Body weights before and after treatment were not reported. During final washout following oat period, serum cholesterol returned toward pretreatment levels further supporting a true effect of oat gum. Short test period.P  `   Bridges, S. et al., 1992 (Ref. 120).@  Clinical study, metabolic ward.@  20 men, ages 38 to 73, mean serum cholesterol range of 252 mg/dL (wheat group) to 305 mg/dL (oat group).0 Subjects received a base diet for 7 days followed by 3 weeks of oat bran or wheat bran supplementation. The base diet was a typical American diet composed of 43% energy from carbohydrate, 16% protein, 41% fat, and 450 mg cholesterol. Treatment = Tx; Pretreatment = Pretx Total dietary fiber = TDF Fiber Intake on Diets Wheat Bran Oat Bran Pretx Tx Pretx Tx TDF, g 18 34 19 34 SF, g 5.6 7.8 6.0 13.4 Oat bran and wheat bran were served as cereal or muffins.H  Wheat Bran Oat Bran  mg/dL  Total CHOL Pretx 252 305 Tx 242 267* LDLCHOL Pretx 130 167 Tx 123 146* *Significantly different from pretx period.H Control period of 7 days is inadequate. Pretreatment serum cholesterol was calculated from data presented. Serum cholesterol and LDLcholesterol between groups is not well matched; oat group had much higher serum and LDLcholesterol than wheat group. Both groups experienced slight but significant weight loss. Not randomized; short test period.8xHH`  `  P  Kashtan et al., 1992 (Ref. 121). Intervention, randomized, metabolically controlled, parallel, doubleblind.X 84 subjects in two groups: group 1 to 42 men and women, mean age 61.3, with history of previous polypectomy; and group 2 to 42 men and women, mean age 51.2, with normal colon and colonic examination. Mean serum cholesterol of group 1: 207 mg/dL; group 2: 227 mg/dL. Subjects were randomly assigned to either the oat bran group or the wheat bran (control) group. Subjects consumed the bran products twice a day for 2 weeks. All food was prepared and delivered to the subjects. Energy content of diet was one of four amounts: 1,600, 2,000, 2,400, and 2,800 calories Ss were fed the amount closest to their requirements based on the Lipid Research Clinics tables. Base diet: 37% fat, 16% protein, 47% carbohydrate; total dietary fiber 24 to 25 g/day. Oat bran supplement: 88.4 g/day: 11 to 17 g fiber; estimated 5 to 8 g SF Wheat bran cream of wheat: 73 g/day: 11 to 17 g fiber/day.`   Before After Change mg/dL Total CHOL Wheat bran 207 198** 0.25 Oat bran 227* 203** 0.63* LDLCHOL Wheat bran 129 125** 0.11 Oat bran 150* 131** 0.48* *Significantly different from wheat bran. **Significantly different from baseline.`  Soluble fiber consumption was not reported. Short term study14 days.`  `   Ranhotra et al., 1989 (Ref. 122).P  Intervention, selfcontrolled.P  17 men, ages 37 to 60 years, hypercholesterolemic (mean serum cholesterol 224 mg/dL), free living. One subject had a history of heart attack and one subject was a type II diabetic.  A 6week control period followed by a 6week test period. Ss consumed their usual diet during the control period but maintained daily records of intake for first 4 weeks. Ss were provided a list of cerealbased and other foods identified as sources of SF and asked to consume these with their daily diets. Additional SF supplement of processed rice bran (30 g) and oat bran (30 g) was provided.  Nutrient Intake: Control Test Energy, Cal. 2378+431 2331+419 Fat, % energy 35.3+4.7 33.9+4.9 Saturated Fat, % 10+1.7 9+1.9 Total fiber, g 15.0+5.8 28.3+4.7 Soluble fiber, g 5.0+1.6 9.4+1.5 Ss individual data were reported. Six of the 17 Ss experienced lowered serum cholesterol of 1 to 17% compared to control values. Statistical analysis not performed by authors. Results are too inconsistent in direction and magnitude to support an effect of SF on serum cholesterol. Some subjects failed to consume the supplement daily. Intake of both soluble and dietary fiber varied greatly among the participants. HxHH`  p  `  Zhang et al., 1992 (Ref. 123). Intervention, randomized, controlled, crossover.h 9 men and women (2 women, 7 men), ages 45 to 67 years, with ileostomies. Mean serum cholesterol231 mg/dL. The goal of this study was to elucidate the cholesterollowering mechanisms of oat bran and to compare the sterol excretion pattern on a basic diet (wheat flour bread, low fiber diet (LFD)) to oat bran (oat bran bread, high fiber diet (HFD)). Subjects were randomly assigned to two groups (LFD or HFD) and each group followed for 3 weeks followed by crossover to the other diet. Ss consumed the bread products with their own food which was modified to be low fiber. wheat flour bread: 4.9 g dietary fiber; oat bran bread: 29 g dietary fiber. p   Serum Cholesterol mg/dL All Ss (n=9) LDF 214 HDF 194.5* Ss with low daily bile acid excretion (n=5) LDF 234 HDF 207* Ss with high daily bile acid excretion (n=4) LDF 189 HDF 179 *Significantly different from LFD. p  Total dietary soluble fiber intake and intake of fat, saturated fat, and cholesterol were not reported. All subjects had ileostomies. Conclusions about fiber mechanisms in lowering serum lipids may not apply to the general population. Short test period.p      Marlett et al., 1992 (Ref. 124).  Intervention, metabolically controlled, single isotope used to determine bile acid kinetics.  9 men, ages 20 to 28 years, normocholesterolemic (estimated range of 131 to 244 mg/dL).  A 2month study: period 1: low fiber control period and period 2: high fiber period with oat bran. Base diets: energy2,700, 3,000, 3,300, and 3,600 Cal/day with 35% fat, 15% protein, and 50% carbohydrate. Foods were consumed in a metabolic unit except an evening snack which could be taken home. Oat bran100 g, provided 16.1% dietary fiber, of which 38% was glucan, and 46% was soluble fiber. Wheat glutenan amount comparable to protein provided by oat bran was included in foods in the low fiber diet.  Low Fiber High Fiber Period Period Mean dietary fiber intake: D.F., g/day 16 33.9 S.F., g/day 4.0 10.3 Serum Cholesterol mg/dL Prestudy Low Fiber High Fiber 177 152* 138** *Significantly lower than prestudy value. **Significantly lower than low fiber period. Total daily fecal bile acid excretion more than doubled when oat bran was incorporated into the metabolic diet: Total B.A., micromoles/day 476.4 1026.2x There were no changes in body weights. Small sample size.   (p