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Cardiovascular Outcomes Of Diet Counseling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00324545
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
GM Harrington, PhD
Information provided by (Responsible Party):
RM Fleming, MD, The Camelot Foundation

Tracking Information
First Submitted Date  ICMJE May 9, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE January 1, 2000
Actual Primary Completion Date December 31, 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
coronary blood flow
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
  • weight
  • BMI
  • LDLc
  • Total Cholesterol
  • HDLc
  • Triglycerides
  • Homocysteine
  • Fibrinogen
  • Lipoprotein (a)
  • VLDLc
  • TC/HDL
  • TG/HDL (Insulin Resistance)
  • CRP
  • IL-6
  • respiratory quotient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Outcomes Of Diet Counseling
Official Title  ICMJE Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets
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?
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Obesity
Intervention  ICMJE Behavioral: Medium-intensity Minimally-directive Counseling
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2006)
120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 31, 2002
Actual Primary Completion Date December 31, 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324545
Other Study ID Numbers  ICMJE 2000-1-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Documents we are uploading onto Clinical Trials site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: We are uploading information onto the Clinical Trials site.
Access Criteria: Direct email request may be made to primary email.
Responsible Party RM Fleming, MD, The Camelot Foundation
Study Sponsor  ICMJE The Camelot Foundation
Collaborators  ICMJE GM Harrington, PhD
Investigators  ICMJE
Principal Investigator: Richard M Fleming, MD Camelot Foundation
Principal Investigator: Gordon M Harrington, PhD University of Northern Iowa
PRS Account The Camelot Foundation
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP