NCT01593605

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

May 2, 2012

Last Update Submit

September 18, 2013

Conditions

Impaired Glucose Tolerance

Keywords

Impaired glucose tolerance, pre-diabetes,glycemic control,supplements

Outcome Measures

Primary Outcomes (1)

  • Glucose Control

    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 Outcomes (1)

  • Metabolic Markers

    28 days

Study Arms (3)

Dietary Supplement/insulin sensitivity

ACTIVE COMPARATOR

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

Sugar Pill

PLACEBO COMPARATOR

Neutral treatment Placebo - one tablet taken twice a day by mouth

Other: Placebo treatment

Dietary Supplement 2

ACTIVE COMPARATOR

2nd study supplement contains resveratrol and HMB which may stimulate protein building.

Dietary Supplement: resveratrol /HMB

Interventions

ResveratrolDIETARY_SUPPLEMENT

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/insulin sensitivity
resveratrol /HMBDIETARY_SUPPLEMENT

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.

Dietary Supplement 2
Placebo treatmentOTHER

Placebo - one tablet taken twice a day by mouth

Sugar Pill

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility: Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (8)

  • 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.

    PMID: 16732220BACKGROUND

  • 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.

    PMID: 15768047BACKGROUND

  • 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.

    PMID: 20863707BACKGROUND

  • 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.

    PMID: 21080630BACKGROUND

  • 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.

    PMID: 15113738BACKGROUND

  • 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.

    PMID: 15761181BACKGROUND

  • 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.

    PMID: 18844841BACKGROUND

  • 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.

    PMID: 17406924BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Kevin D Niswender, MD,PHD

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Sub-Investigator/Coordinator

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 8, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

US(1)