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Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

NCT01593605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-09-20

No results posted yet for this study

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.

Conditions

  • Impaired Glucose Tolerance

Interventions

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

Sponsors & Collaborators

  • Nutraceutical Discoveries, Inc.

    collaborator OTHER

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Kevin D Niswender, MD,PHD · Vanderbilt University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593605 on ClinicalTrials.gov