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Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

This study has been completed.
Sponsor:
Collaborator:
Nutraceutical Discoveries, Inc.
Information provided by (Responsible Party):
Wanda Snead, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01593605
First received: May 2, 2012
Last updated: September 18, 2013
Last verified: September 2013

May 2, 2012
September 18, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
Glucose Control [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01593605 on ClinicalTrials.gov Archive Site
Metabolic Markers [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Impaired Glucose Tolerance
  • Dietary Supplement: Resveratrol
    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).
  • Dietary Supplement: resveratrol /HMB
    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.
  • Other: Placebo treatment
    Placebo - one tablet taken twice a day by mouth
  • 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
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Sugar Pill
    Neutral treatment Placebo - one tablet taken twice a day by mouth
    Intervention: Other: Placebo treatment
  • Active Comparator: Dietary Supplement 2
    2nd study supplement contains resveratrol and HMB which may stimulate protein building.
    Intervention: Dietary Supplement: resveratrol /HMB

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01593605
KNIS-NCI
Yes
Wanda Snead, Vanderbilt University
Vanderbilt University
Nutraceutical Discoveries, Inc.
Principal Investigator: Kevin D Niswender, MD,PHD Vanderbilt University School of Medicine
Vanderbilt University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP