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OpenTrials
Completed

NCT Number: NCT02379897

Diet, Obesity and Cardiovascular Risk Study

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

Primary outcomes

  1. Change in body weight

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change in fasting plasma high density lipoprotein cholesterol

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  2. Change in fasting plasma low density lipoprotein cholesterol-cholesterol

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  3. Change in fasting plasma very low density lipoprotein cholesterol-cholesterol

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  4. Change in fasting plasma triglycerides

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  5. Change in fasting plasma insulin

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  6. Change in fasting blood glucose

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  7. Change in glycated hemoglobin

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  8. Change in plasma C-reactive protein

    Time frame: Baseline to 12 weeks, 17 weeks, and 16 months

  9. Change in body fat

    Time frame: Baseline to 12 weeks and 17 weeks

  10. Change in resting metabolic rate

    Time frame: Baseline to 12 weeks and 17 weeks

  11. Change in blood pressure

    Time frame: Baseline to 12weeks, 17weeks and 16months

  12. Change in body weight

    Time frame: Baseline to 17weeks and 16months

  13. Change in postprandial blood glucose

    Time frame: Baseline to 12weeks and 17weeks

    Oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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