Diet, Obesity and Cardiovascular Risk Study

Tufts University

Status: Completed

Conditions: Obesity; Cardiovascular Diseases

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02379897

R01HL 57981

Details and patient eligibility

About

Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks, then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.

Enrollment: 107 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 28-28 kg/m2
• Male or postmenopausal female 45-65 yr

Exclusion criteria

• Abnormal thyroid, liver, kidney function
• Abnormal hemoglobin
• LDL-cholesterol ≤ 100 mg/dL
• Fasting triglycerides ≥ 400 mg/dL
• Diabetes or on medication for diabetes
• Chronic illness
• Elevated blood lipids

Trial design

107 participants in 4 patient groups

LowGI+ModCarb

Experimental group

Description:

Low glycemic index + moderate carbohydrate/moderate fat diet

Treatment:

Other: Diet

LowGI+HighCarb

Experimental group

Description:

Low glycemic index + high carbohydrate/low fat diet

Treatment:

Other: Diet

HighGI+ModCarb

Experimental group

Description:

High glycemic index + moderate carbohydrate/moderate fat diet

Treatment:

Other: Diet

HighGI+HighCarb

Experimental group

Description:

High glycemic index + high carbohydrate/low fat diet

Treatment:

Other: Diet