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Cardiovascular Outcomes Of Diet Counseling

This study has been completed.
Sponsor:
Information provided by:
The Camelot Foundation
ClinicalTrials.gov Identifier:
NCT00324545
First received: May 9, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Keywords provided by The Camelot Foundation:
Obesity
Diets
Heart Disease
Randomized controlled trial
Ischemia.

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015