Cardiovascular Outcomes Of Diet Counseling

NCT00324545 | Completed Phase 3

• 1 other identifier: 2000-1-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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?

Conditions

Coronary Artery Disease; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• coronary blood flow

Secondary Outcomes (15)

• weight

• BMI

• LDLc

• Total Cholesterol

• HDLc

Interventions

Medium-intensity Minimally-directive Counseling BEHAVIORAL

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• The Camelot Foundation: lead
• GM Harrington, PhD: collaborator

Study Sites (2)

Keith Block

Chicago, Illinois, 60201, United States

Location

Richard M. Fleming, MD

Omaha, Nebraska, 68114, United States

Location

Related Publications (14)

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

  PMID: 847061 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  PMID: 2064490 BACKGROUND

• 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. doi: 10.1001/jama.276.8.637. No abstract available.

  PMID: 8773637 BACKGROUND

• 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. doi: 10.1093/jn/136.2.440.

  PMID: 16424125 BACKGROUND

• 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. doi: 10.1001/jama.293.1.43.

  PMID: 15632335 BACKGROUND

• DAVIS CM. Self regulation of diet in childhood. Health Educ J (Los Angel). 1947 Jan;5:37-40. doi: 10.1177/001789694700500110. No abstract available.

  PMID: 20247154 BACKGROUND

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

  BACKGROUND

• Fleming RM. The effect of high-protein diets on coronary blood flow. Angiology. 2000 Oct;51(10):817-26. doi: 10.1177/000331970005101003.

  PMID: 11108325 BACKGROUND

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

  PMID: 10959514 BACKGROUND

• 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. doi: 10.1111/j.1520-037x.2002.01231.x.

  PMID: 12091753 BACKGROUND

• Fleming RM, Ketchum K, Fleming DM, Gaede R. Treating hyperlipidemia in the elderly. Angiology. 1995 Dec;46(12):1075-83. doi: 10.1177/000331979504601202.

  PMID: 7495312 BACKGROUND

• 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. doi: 10.1177/000331979604700901.

  PMID: 8810649 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Obesity; Heart Diseases; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Richard M Fleming, MD

  Camelot Foundation

  PRINCIPAL INVESTIGATOR

• Gordon M Harrington, PhD

  University of Northern Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: January 1, 2000
• Primary Completion: December 31, 2002
• Study Completion: December 31, 2002
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (2)