Cardiovascular Outcomes Of Diet Counseling - Full Text View

Sponsored by:	The Camelot Foundation
Information provided by:	The Camelot Foundation
ClinicalTrials.gov Identifier:	NCT00324545

Purpose

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Condition	Intervention	Phase
Coronary Artery Disease Obesity	Behavioral: Medium-intensity Minimally-directive Counseling	Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-Intensity Minimally-Directive Counseling for Different Diets

Further study details as provided by The Camelot Foundation:

Primary Outcome Measures:

coronary blood flow

Secondary Outcome Measures:

weight
BMI
LDLc
Total Cholesterol
HDLc
Triglycerides
Homocysteine
Fibrinogen
Lipoprotein (a)
VLDLc
TC/HDL
TG/HDL (Insulin Resistance)
CRP
IL-6
respiratory quotient

Estimated Enrollment:	120
Study Start Date:	January 2000
Estimated Study Completion Date:	December 2002

Detailed Description:

Given the current epidemic of overweight and obesity on a global scale (“globesity”) and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity.

Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Eligibility

Ages Eligible for Study:	30 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria: BMI greater than 30,

Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324545

Locations

United States, Illinois
Keith Block
Chicago, Illinois, United States, 60201
United States, Nebraska
Richard M. Fleming, MD
Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

The Camelot Foundation

Investigators

Principal Investigator:	Richard M Fleming, MD	Camelot Foundation
Principal Investigator:	Gordon M Harrington, PhD	University of Northern Iowa

More Information

Not for Profit Organization This link exits the ClinicalTrials.gov site

Publications:

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. No abstract available.

Barnard RJ. Effects of life-style modification on serum lipids. Arch Intern Med. 1991 Jul;151(7):1389-94.

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996 Aug 28;276(8):637-9. No abstract available.

Cantwell MM, Millen AE, Carroll R, Mittl BL, Hermansen S, Brinton LA, Potischman N. A debriefing session with a nutritionist can improve dietary assessment using food diaries. J Nutr. 2006 Feb;136(2):440-5.

Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53.

Davis, C. M. (1947). Self-regulation of diet in childhood. Health Education Journal (London), 5, 37-40.

Fleming, R. M. (1999). The pathogenesis of vascular disease. In J. Chang (Ed.), The Textbook of Angiology (pp. 787-798). New York: Springer-Verlag.

Fleming RM. The effect of high-protein diets on coronary blood flow. Angiology. 2000 Oct;51(10):817-26.

Fleming RM. Reversing heart disease in the new millennium--the Fleming unified theory. Angiology. 2000 Aug;51(8):617-29.

Fleming RM. The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors. Prev Cardiol. 2002 Summer;5(3):110-8. Erratum in: Prev Cardiol 2002 Fall;5(4):203.

Fleming, R. M., Ketchum, K., Fleming, D. M., & Gaede, R. (1995). Treating hyperlipidemia in the elderly. Angiology, 46(12), 1075-1083.

Fleming RM, Ketchum K, Fleming DM, Gaede R. Assessing the independent effect of dietary counseling and hypolipidemic medications on serum lipids. Angiology. 1996 Sep;47(9):831-40.

Study ID Numbers:	2000-1-1
Study First Received:	May 9, 2006
Last Updated:	May 9, 2006
ClinicalTrials.gov Identifier:	NCT00324545
Health Authority:	United States: Institutional Review Board

Keywords provided by The Camelot Foundation:

Obesity
Diets
Heart Disease
Randomized controlled trial
Ischemia.

Study placed in the following topic categories:

Arterial Occlusive Diseases
Obesity
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Overweight
Ischemia

Arteriosclerosis
Coronary Disease
Body Weight
Signs and Symptoms
Nutrition Disorders
Overnutrition
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009