Dietary Protein and Insulin Sensitivity Study
Completed · Not applicable
Conditions studied: Insulin Resistance, Type 2 Diabetes, Metabolic Syndrome, Cardiovascular Disease, Dyslipidemia
In brief
The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.
Key facts
- Study ID
- NCT00508937
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 660
- Starts
- 2007-02-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2020-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
- HOMA-IR ≥ 2.5
- Non-smoking
- Total cholesterol and LDL cholesterol <95th percentile for sex and age
- Fasting triglycerides < 500mg/dl
- Fasting blood sugar < 126
- Urinary microalbumin < 30 mg/L
- Normal thyroid stimulating hormone levels
- Hematocrit ≥ 36%
- Blood pressure < 150/90
- At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase
You may not qualify if…
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
- Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
- Use of alcohol or dietary supplements during the study
- Pregnancy
Where it is running
- Cholesterol Research Center — Berkeley, California, United States
- San Francisco General Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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