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Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease

Primary Purpose

Obesity, Cardiovascular Disease, Metabolic Syndrome

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Low glycemic load diet
Canada Food Guide Diet
Low glycemic index diet
Low carbohydrate diet
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Cardiovascular Disease, Metabolic Syndrome, Canada Food Guide, Glycemic Index, Glycemic Load

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women, aged 18 to 80 years BMI 25-40 kg/m2 Documented Cardiovascular Disease as evidenced by one or more of the following: Coronary atherosclerosis during coronary angiography Documented myocardial infarction Carotid atherosclerosis during carotid ultrasonography Carotid atherosclerosis during CT angiography Carotid atherosclerosis during MR angiography Ischemic brain infarct documented on brain imaging studies Exclusion Criteria: Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada) Previous (<5 years ago) individual or group dietary counseling with a registered dietician Pregnant or lactating women Presence of clinically important hepatic or renal disease Inability to communicate effectively using the English language Enrollment in another study concurrently Inability to give informed consent

Sites / Locations

  • Vascular Disease Prevention and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1

2

3

4

Arm Description

Low glycemic load diet

Canada Food Guide Diet

Low glycemic index diet

Low carbohydrate diet

Outcomes

Primary Outcome Measures

To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.

Secondary Outcome Measures

To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.

Full Information

First Posted
September 9, 2005
Last Updated
January 27, 2009
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00229229
Brief Title
Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease
Official Title
Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load. To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet. The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.
Detailed Description
The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease. The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se. A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Disease, Metabolic Syndrome
Keywords
Obesity, Cardiovascular Disease, Metabolic Syndrome, Canada Food Guide, Glycemic Index, Glycemic Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Low glycemic load diet
Arm Title
2
Arm Type
Other
Arm Description
Canada Food Guide Diet
Arm Title
3
Arm Type
Other
Arm Description
Low glycemic index diet
Arm Title
4
Arm Type
Other
Arm Description
Low carbohydrate diet
Intervention Type
Other
Intervention Name(s)
Low glycemic load diet
Intervention Description
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Intervention Type
Other
Intervention Name(s)
Canada Food Guide Diet
Intervention Description
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Intervention Type
Other
Intervention Name(s)
Low glycemic index diet
Intervention Description
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Intervention Type
Other
Intervention Name(s)
Low carbohydrate diet
Intervention Description
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Primary Outcome Measure Information:
Title
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, aged 18 to 80 years BMI 25-40 kg/m2 Documented Cardiovascular Disease as evidenced by one or more of the following: Coronary atherosclerosis during coronary angiography Documented myocardial infarction Carotid atherosclerosis during carotid ultrasonography Carotid atherosclerosis during CT angiography Carotid atherosclerosis during MR angiography Ischemic brain infarct documented on brain imaging studies Exclusion Criteria: Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada) Previous (<5 years ago) individual or group dietary counseling with a registered dietician Pregnant or lactating women Presence of clinically important hepatic or renal disease Inability to communicate effectively using the English language Enrollment in another study concurrently Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A LaHaye, MD
Organizational Affiliation
Vascular Disease Prevention and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Disease Prevention and Research Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

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Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease

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