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

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00229229
First received: September 9, 2005
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Obesity
Cardiovascular Disease
Metabolic Syndrome
Other: Low glycemic load diet
Other: Canada Food Guide Diet
Other: Low glycemic index diet
Other: Low carbohydrate diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Queen's University:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: September 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
4
Low carbohydrate diet
Other: Low carbohydrate diet
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229229

Locations
Canada, Ontario
Vascular Disease Prevention and Research Centre
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Stephen A LaHaye, MD Vascular Disease Prevention and Research Centre
  More Information

No publications provided

Responsible Party: Stephen LaHaye MD,FRCP, QUEEN'S UNIVERSITY
ClinicalTrials.gov Identifier: NCT00229229     History of Changes
Other Study ID Numbers: DMED-793-04
Study First Received: September 9, 2005
Last Updated: January 27, 2009
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Obesity
Cardiovascular Disease
Metabolic Syndrome
Canada Food Guide
Glycemic Index
Glycemic Load

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Vascular Diseases
Overweight
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014