Cardiovascular Outcomes Of Diet Counseling

• ClinicalTrials.gov Identifier: NCT00324545
• Recruitment Status: Completed
• First Posted: May 11, 2006
• Last Update Posted: July 21, 2020
• Sponsor: The Camelot Foundation
• Collaborator: GM Harrington, PhD
• Information provided by (Responsible Party): RM Fleming, MD, 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 3

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)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• 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
• Actual Study Start Date: January 1, 2000
• Actual Primary Completion Date: December 31, 2002
• Study Completion Date: December 31, 2002

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. coronary blood flow

Secondary Outcome Measures :

1. weight
2. BMI
3. LDLc
4. Total Cholesterol
5. HDLc
6. Triglycerides
7. Homocysteine
8. Fibrinogen
9. Lipoprotein (a)
10. VLDLc
11. TC/HDL
12. TG/HDL (Insulin Resistance)
13. CRP
14. IL-6
15. respiratory quotient

Eligibility Criteria

• 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

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

GM Harrington, PhD

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.

• Responsible Party: RM Fleming, MD, PI, The Camelot Foundation
• ClinicalTrials.gov Identifier: NCT00324545
• Other Study ID Numbers: 2000-1-1
• First Posted: May 11, 2006
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Documents we are uploading onto Clinical Trials site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: We are uploading information onto the Clinical Trials site.
• Access Criteria: Direct email request may be made to primary email.

Keywords provided by RM Fleming, MD, The Camelot Foundation:

Obesity; Diets; Heart Disease; Randomized controlled trial; Ischemia.

Additional relevant MeSH terms:

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