Diet, Obesity and Cardiovascular Risk Study

Obesity Clinical Trial

Official title:

Diet, Obesity and Cardiovascular Risk Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379897
• Other study ID #: R01HL 57981
• Status: Completed
• Phase: N/A
• First received: February 14, 2015
• Last updated: February 27, 2015
• Start date: September 2000
• Est. completion date: January 2004

Study information

• Verified date: February 2015
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Other:
• Diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline to 12 weeks	No
Secondary	Change in fasting plasma high density lipoprotein cholesterol		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in fasting plasma low density lipoprotein cholesterol-cholesterol		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in fasting plasma very low density lipoprotein cholesterol-cholesterol		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in fasting plasma triglycerides		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in fasting plasma insulin		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in fasting blood glucose		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in glycated hemoglobin		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in plasma C-reactive protein		Baseline to 12 weeks, 17 weeks, and 16 months	No
Secondary	Change in body fat		Baseline to 12 weeks and 17 weeks	No
Secondary	Change in resting metabolic rate		Baseline to 12 weeks and 17 weeks	No
Secondary	Change in blood pressure		Baseline to 12weeks, 17weeks and 16months	No
Secondary	Change in body weight		Baseline to 17weeks and 16months	No
Secondary	Change in postprandial blood glucose	Oral glucose tolerance test	Baseline to 12weeks and 17weeks	No