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Cardiovascular Outcomes Of Diet Counseling

Primary Purpose

Coronary Artery Disease, Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Medium-intensity Minimally-directive Counseling
Sponsored by
The Camelot Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Obesity, Diets, Heart Disease, Randomized controlled trial, Ischemia.

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Keith Block
  • Richard M. Fleming, MD

Outcomes

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

Full Information

First Posted
May 9, 2006
Last Updated
July 20, 2020
Sponsor
The Camelot Foundation
Collaborators
GM Harrington, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT00324545
Brief Title
Cardiovascular Outcomes Of Diet Counseling
Official Title
Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2000 (Actual)
Primary Completion Date
December 31, 2002 (Actual)
Study Completion Date
December 31, 2002 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Camelot Foundation
Collaborators
GM Harrington, PhD

4. Oversight

5. 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?
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Obesity
Keywords
Obesity, Diets, Heart Disease, Randomized controlled trial, Ischemia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Medium-intensity Minimally-directive Counseling
Primary Outcome Measure Information:
Title
coronary blood flow
Secondary Outcome Measure Information:
Title
weight
Title
BMI
Title
LDLc
Title
Total Cholesterol
Title
HDLc
Title
Triglycerides
Title
Homocysteine
Title
Fibrinogen
Title
Lipoprotein (a)
Title
VLDLc
Title
TC/HDL
Title
TG/HDL (Insulin Resistance)
Title
CRP
Title
IL-6
Title
respiratory quotient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Fleming, MD
Organizational Affiliation
Camelot Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon M Harrington, PhD
Organizational Affiliation
University of Northern Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keith Block
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Richard M. Fleming, MD
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Documents we are uploading onto Clinical Trials site.
IPD Sharing Time Frame
We are uploading information onto the Clinical Trials site.
IPD Sharing Access Criteria
Direct email request may be made to primary email.
Citations:
PubMed Identifier
847061
Citation
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Cardiovascular Outcomes Of Diet Counseling

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