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

January 27, 2009 updated by: Queen's University

Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Vascular Disease Prevention and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Low glycemic load diet
Other: Low glycemic load diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Other: 2
Canada Food Guide Diet
Other: Canada Food Guide Diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Other: 3
Low glycemic index diet
Other: Low glycemic index diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Other: 4
Low carbohydrate diet
Other: Low carbohydrate diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Stephen A LaHaye, MD, Vascular Disease Prevention and Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-793-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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