- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593605
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
September 18, 2013 updated by: Wanda Snead, Vanderbilt University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a 28-day randomized controlled trial of the effects of a nutraceutical preparation on glycemic control in non-diabetic individuals with impaired glucose tolerance (IGT).
IGT will be defined by American Diabetes Association criteria, as outlined in the list of inclusion and exclusion criteria (copy attached).
There will be two active treatment arms and a placebo arm (3 arms total, n=12 completed subjects per arm).
Following screening for inclusion/exclusion criteria and obtaining informed consent, subjects will be enrolled in the study and provided instructions to maintain their usual dietary pattern and physical activity level.
If recent physical examination and medical history are not available; H&P will be conducted and recorded for each enrolled subject.
Subjects will be instructed to follow a 12-hour fast starting on day -1, and on the morning of day 0 fasting blood is drawn for analyses indicated below and the supplements are distributed.
Supplements are distributed using a blinding protocol and a variable, known pill allotment in order to assess compliance via standard pill counts.
Pill bottles and all unused supplements are returned at seven day intervals, with new supplies being distributed at that time.
Fasting blood samples are obtained on days 0, 7, 14 and 28.
Samples from each day are analyzed for glucose and insulin.
Samples from days 0, 14 and 28 are also analyzed for fructosamine, C-peptide, glucagon and F2-isoprostanes.
A75 g oral glucose tolerance test administered on days 0 and 28.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Facility: Vanderbilt University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dietary Supplement/insulin sensitivity
The first study supplement contains resveratrol that may improve insulin sensitivity and Leucine.Resveratrol 50mg with leucine 1.11 g. - one tablet taken twice a day by mouth
|
A blend of low dose resveratrol and either leucine or HMB will be useful nutraceutical strategies for the control of elevated blood glucose in non-diabetic individuals with elevated fasting glucose.
The proposed project is designed to evaluate this hypothesis by comparing the effects of resveratrol (50 mg)/leucine (1.11 g) administered twice daily (bid).
|
Placebo Comparator: Sugar Pill
Neutral treatment Placebo - one tablet taken twice a day by mouth
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Placebo - one tablet taken twice a day by mouth
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Active Comparator: Dietary Supplement 2
2nd study supplement contains resveratrol and HMB which may stimulate protein building.
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resveratrol (50 mg)/HMB (500 mg) twice daily (bid) with placebo on fasting blood glucose, glucose tolerance, insulin, C-peptide, glucagon, fructosamine and F2-isoprostanes in non-diabetic subjects with elevated fasting blood glucose.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Control
Time Frame: 28 days
|
We 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
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Markers
Time Frame: 28 days
|
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
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin D Niswender, MD,PHD, Vanderbilt University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baur JA, Sinclair DA. Therapeutic potential of resveratrol: the in vivo evidence. Nat Rev Drug Discov. 2006 Jun;5(6):493-506. doi: 10.1038/nrd2060. Epub 2006 May 26.
- Bordone L, Guarente L. Calorie restriction, SIRT1 and metabolism: understanding longevity. Nat Rev Mol Cell Biol. 2005 Apr;6(4):298-305. doi: 10.1038/nrm1616.
- Verdin E, Hirschey MD, Finley LW, Haigis MC. Sirtuin regulation of mitochondria: energy production, apoptosis, and signaling. Trends Biochem Sci. 2010 Dec;35(12):669-75. doi: 10.1016/j.tibs.2010.07.003. Epub 2010 Sep 20.
- Blum CA, Ellis JL, Loh C, Ng PY, Perni RB, Stein RL. SIRT1 modulation as a novel approach to the treatment of diseases of aging. J Med Chem. 2011 Jan 27;54(2):417-32. doi: 10.1021/jm100861p. Epub 2010 Nov 16. No abstract available.
- Zemel MB. Role of calcium and dairy products in energy partitioning and weight management. Am J Clin Nutr. 2004 May;79(5):907S-912S. doi: 10.1093/ajcn/79.5.907S.
- Zemel MB. Calcium and dairy modulation of obesity risk. Obes Res. 2005 Jan;13(1):192-3. doi: 10.1038/oby.2005.26. No abstract available.
- Zemel MB, Sun X. Calcitriol and energy metabolism. Nutr Rev. 2008 Oct;66(10 Suppl 2):S139-46. doi: 10.1111/j.1753-4887.2008.00099.x.
- Sun X, Zemel MB. Leucine and calcium regulate fat metabolism and energy partitioning in murine adipocytes and muscle cells. Lipids. 2007 Apr;42(4):297-305. doi: 10.1007/s11745-007-3029-5. Epub 2007 Feb 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 2, 2012
First Submitted That Met QC Criteria
May 7, 2012
First Posted (Estimate)
May 8, 2012
Study Record Updates
Last Update Posted (Estimate)
September 20, 2013
Last Update Submitted That Met QC Criteria
September 18, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hyperglycemia
- Prediabetic State
- Glucose Intolerance
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Antioxidants
- Resveratrol
Other Study ID Numbers
- KNIS-NCI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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