Diet, Obesity and Cardiovascular Risk Study
1 other identifier
interventional
107
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Sep 2000
Typical duration for not_applicable cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 14, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedMarch 5, 2015
February 1, 2015
3.3 years
February 14, 2015
February 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in body weight
Baseline to 12 weeks
Secondary Outcomes (13)
Change in fasting plasma high density lipoprotein cholesterol
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma low density lipoprotein cholesterol-cholesterol
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma very low density lipoprotein cholesterol-cholesterol
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma triglycerides
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma insulin
Baseline to 12 weeks, 17 weeks, and 16 months
- +8 more secondary outcomes
Study Arms (4)
LowGI+ModCarb
EXPERIMENTALLow glycemic index + moderate carbohydrate/moderate fat diet
LowGI+HighCarb
EXPERIMENTALLow glycemic index + high carbohydrate/low fat diet
HighGI+ModCarb
EXPERIMENTALHigh glycemic index + moderate carbohydrate/moderate fat diet
HighGI+HighCarb
EXPERIMENTALHigh glycemic index + high carbohydrate/low fat diet
Interventions
Eligibility Criteria
You may qualify if:
- BMI 28-28 kg/m2
- Male or postmenopausal female 45-65 yr
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
February 14, 2015
First Posted
March 5, 2015
Study Start
September 1, 2000
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
March 5, 2015
Record last verified: 2015-02