Cardiovascular Outcomes Of Diet Counseling

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ClinicalTrials.gov Identifier: NCT00324545

Recruitment Status : Completed

First Posted : May 11, 2006

Last Update Posted : May 11, 2006

Sponsor:

Information provided by:

The Camelot Foundation

Study Description

Brief Summary:

(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 or disease	Intervention/treatment	Phase
Coronary Artery Disease Obesity	Behavioral: Medium-intensity Minimally-directive Counseling	Phase 2

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?

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Long-Term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-Intensity Minimally-Directive Counseling for Different Diets
Study Start Date :	January 2000
Study Completion Date :	December 2002

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215.

Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. xiii, 617.

Bandura, A. (1997). Self-efficacy: The exercise of control. ix, 604.

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.

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 CM. Self regulation of diet in childhood. Health Educ J. 1947 Jan;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 RM, Ketchum K, Fleming DM, Gaede R. Treating hyperlipidemia in the elderly. Angiology. 1995 Dec;46(12):1075-83.

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.


ClinicalTrials.gov Identifier:	NCT00324545 History of Changes
Other Study ID Numbers:	2000-1-1
First Posted:	May 11, 2006 Key Record Dates
Last Update Posted:	May 11, 2006
Last Verified:	May 2006

Keywords provided by The Camelot Foundation:


Obesity Diets Heart Disease Randomized controlled trial Ischemia.

Additional relevant MeSH terms:


Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

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