Clinical Trials Directory

Trials / Terminated

TerminatedNCT00229229

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

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Queen's University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLow glycemic load dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
OTHERCanada Food Guide DietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
OTHERLow glycemic index dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
OTHERLow carbohydrate dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

Timeline

Start date
2004-09-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2005-09-29
Last updated
2009-01-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00229229. Inclusion in this directory is not an endorsement.