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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
  Purpose

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.


Condition Intervention
Impaired Glucose Tolerance
Dietary Supplement: Resveratrol
Dietary Supplement: resveratrol /HMB
Other: Placebo treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
Placebo Comparator: Sugar Pill
Neutral treatment Placebo - one tablet taken twice a day by mouth
Other: Placebo treatment
Placebo - one tablet taken twice a day by mouth
Active Comparator: Dietary Supplement 2
2nd study supplement contains resveratrol and HMB which may stimulate protein building.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593605

Locations
United States, Tennessee
Facility: Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Nutraceutical Discoveries, Inc.
Investigators
Principal Investigator: Kevin D Niswender, MD,PHD Vanderbilt University School of Medicine
  More Information

Publications:
Responsible Party: Wanda Snead, Study Sub-Investigator/Coordinator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01593605     History of Changes
Other Study ID Numbers: KNIS-NCI
Study First Received: May 2, 2012
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Impaired glucose tolerance, pre-diabetes,glycemic control,
supplements

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Resveratrol
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014