Safety and Effectiveness Study of a Fiber Supplement for Weight Loss - Full Text View

Sponsored by:	Rush University Medical Center
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00613600

Purpose

Overweight and obesity are serious and growing problems within the United States. The usual approaches to weight loss-dieting, exercise, and behavioral interventions-rarely result in long-term weight loss. Therefore, we will evaluate the safety and efficacy of glucomannan, a fiber supplement that has promising weight loss effects.

Condition	Intervention	Phase
Overweight Obesity	Dietary Supplement: Glucomannan Dietary Supplement: Inert microcrystalline cellulose	Phase II

MedlinePlus related topics: Dietary Supplements Obesity Weight Control

Drug Information available for: Cellulose Cellulose sodium phosphate Phosphocellulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Glucomannan for Weight Loss

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

Weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body composition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Dietary intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hunger and fullness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Lipid profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Fasting blood glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
C-reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Gastrointestinal symptoms and tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Hepatic panel [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Serum creatinine [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Two 665 mg capsules of glucomannan three times a day for eight weeks	Dietary Supplement: Glucomannan Two 665 mg capsules of glucomannan three times a day for 8 weeks
2: Placebo Comparator Two capsules of inert microcrystalline cellulose three times a day for eight weeks	Dietary Supplement: Inert microcrystalline cellulose Two capsules of inert microcrystalline cellulose three times a day for eight weeks

Detailed Description:

The primary objective of this exploratory project is to evaluate the safety and efficacy of a highly viscous, water-soluble fiber supplement, glucomannan, for achieving weight loss in overweight and moderately obese individuals. Overweight and obesity are major public health problems in the U.S. that account for substantial morbidity, mortality, and healthcare costs. Conventional approaches to weight loss are largely ineffective, particularly for long-term weight loss and maintenance. Thus, there is a critical need for safe and effective adjunctive treatments. A few, limited studies suggest that glucomannan supplementation is associated with weight loss, is well-tolerated, and has a favorable safety profile.

In this preliminary study, the target population will be overweight and moderately obese individuals, a population that accounts for nearly 50% of all U.S. adults. The specific aims of the project are to: 1) describe the safety of glucomannan for achieving weight loss in overweight and moderately obese individuals, and 2) describe the efficacy of glucomannan for achieving weight loss in overweight and moderately obese individuals. Participants will take glucomannan supplements daily for eight weeks in a double-blind, placebo-controlled, randomized clinical trial. Safety and efficacy outcome measures include: gastrointestinal symptoms/tolerance, hepatic panel, serum creatinine, weight, body composition, diet intake, hunger/fullness, lipid profile, blood glucose, and C-reactive protein. Examination of the safety and efficacy of glucomannan for achieving weight loss will extend our understanding of additional treatments that may be effective in combating a significant public health problem.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age > or = 18 and < or = 65 years
body mass index (BMI) > or = 25 and < or = 35 at study entry
speak and understand English (since translated versions of study tools have not been validated)
for females only: without childbearing potential or negative HCG hormone blood test and use of an appropriate form of contraception
signed informed consent form and HIPAA research authorization

Exclusion Criteria:

current use of fiber supplements or intolerance to fiber supplements
untreated/unstable metabolic conditions known to influence weight status (e.g., hypothyroidism, type 2 diabetes mellitus)
gastrointestinal disorders that might cause complications or influence motility or satiety (e.g., diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
Stage II hypertension (> or = 160/100 mg Hg) or dyslipidemia (fasting LDL cholesterol > or = 160 mg/dL; total cholesterol > or = 240 mg/dL; triglycerides > 200 mg/dL; HDL < or = 40 mg/dL)
fasting serum glucose > 126 mg/dL
acute or unstable cardiovascular, pulmonary, hepatic, renal, or psychiatric disorders
conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
use of medications that might affect weight or food absorption (e.g., diuretics, glucocorticoids, anorexigenic agents, Orlistat, laxatives)
use of CAM therapies that might affect weight (e.g., acupuncture, Hoodia)
weight change of > 5% body weight within 3 months of entry into the study
active eating disorders or active participation in a weight loss program
renal function impairment as evidenced by a history of renal disease or a serum creatinine > 2.0 mg/dL
liver function impairment as evidenced by a history of liver disease or liver enzyme elevations > three times the upper limit of normal (i.e., ALT > 150 u/L and/or AST > 165 u/L)
evidence of depression as determined by a weighted score of > or = 16 on the Center for Epidemiological Studies Depression Scale (CES-D), as this may affect eating behavior and adherence to the study protocol
currently consumes > or = 10 alcoholic drinks/week, as determined by self-report
currently smokes cigarettes due to the effects of nicotine on appetite and C-reactive protein levels
use of illicit drugs currently or in the last six months, as determined by self-report
for females only: pregnant, less than 6 months postpartum or 6 months post-termination of pregnancy, or currently lactating, due to lack of safety data in this population

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613600

Locations

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator:

Joyce K Keithley, DNSc, RN

Rush University Medical Center

More Information

Responsible Party:	Rush University Medical Center ( Joyce K. Keithley, Professor )
Study ID Numbers:	RTF-GM
Study First Received:	January 31, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00613600
Health Authority:	United States: Institutional Review Board

Keywords provided by Rush University Medical Center:

Safety
Efficacy
Glucomannan
Dietary fiber
Weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
(1-6)-alpha-glucomannan
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Cathartics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009