- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324545
Cardiovascular Outcomes Of Diet Counseling
Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60201
- Keith Block
-
-
Nebraska
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Omaha, Nebraska, United States, 68114
- Richard M. Fleming, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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coronary blood flow
|
Secondary Outcome Measures
Outcome Measure |
---|
Fibrinogen
|
weight
|
CRP
|
BMI
|
Triglycerides
|
IL-6
|
LDLc
|
Total Cholesterol
|
HDLc
|
Homocysteine
|
Lipoprotein (a)
|
VLDLc
|
TC/HDL
|
TG/HDL (Insulin Resistance)
|
respiratory quotient
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard M Fleming, MD, Camelot Foundation
- Principal Investigator: Gordon M Harrington, PhD, University of Northern Iowa
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1177/000331970005101003.
- 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. doi: 10.1111/j.1520-037x.2002.01231.x. 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. doi: 10.1177/000331979504601202.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000-1-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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