Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Impaired Glucose Tolerance

In brief

The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their ability to control glucose levels in persons without diabetes but with impaired fasting glucose. Secondary assessments will examine the effect of these nutritional supplements versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term metabolic markers of risk in diabetes.

Key facts

Study ID

NCT01593605

Run by

Vanderbilt University

People needed

36

Starts

2012-02-01

Expected to finish

2013-06-01

Last updated by the study team

2013-09-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Impaired fasting glucose as defined by American Diabetes Association criteria: fasting plasma glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125 mg/dL)
• Body mass index (BMI) 25-34.9
• Age 18 and above• Weight stable: no more than 1 kg weight gain or loss during past 12 weeks

You may not qualify if…

• Fasting glucose >126 or <99 mg/dL
• BMI < 25 or >35
• Current/previous diagnosis of diabetes
• History of eating disorder or presence of active gastrointestinal disorders such as malabsorption syndromes
• Pregnancy or lactation Anemia, defined as hemoglobin level less than 10g/dl.
• Use of obesity pharmacotherapeutic agents within the last 6 months
• Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropylamine , ephedrine and/or caffeine) within the last 3 months
• Chronic use of anti-inflammatory agents within the last four weeks
• Use of antioxidant supplements within the last four weeks including selenium, vitamin E, vitamin C and/or carotenoids
• Use of supplements containing any of the study compounds within the past four weeks
• Recent (current or past 12 weeks) use of any psychotropic medication
• Recent (past four weeks) initiation of or change in an exercise program
• Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
• Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
• Recent (past 12-weeks) history of tobacco use
• Any Condition that the P.I. considers adverse to the participant

Where it is running

• Facility: Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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