Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resveratrol
resveratrol /HMB
Placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring Impaired glucose tolerance, pre-diabetes,glycemic control,, supplements
Eligibility 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
Sites / Locations
- Facility: Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Dietary Supplement/insulin sensitivity
Sugar Pill
Dietary Supplement 2
Arm Description
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
Neutral treatment Placebo - one tablet taken twice a day by mouth
2nd study supplement contains resveratrol and HMB which may stimulate protein building.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Metabolic Markers
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
Full Information
NCT ID
NCT01593605
First Posted
May 2, 2012
Last Updated
September 18, 2013
Sponsor
Vanderbilt University
Collaborators
Nutraceutical Discoveries, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01593605
Brief Title
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Official Title
Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Nutraceutical Discoveries, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Impaired glucose tolerance, pre-diabetes,glycemic control,, supplements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Supplement/insulin sensitivity
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Neutral treatment Placebo - one tablet taken twice a day by mouth
Arm Title
Dietary Supplement 2
Arm Type
Active Comparator
Arm Description
2nd study supplement contains resveratrol and HMB which may stimulate protein building.
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol /HMB
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo treatment
Intervention Description
Placebo - one tablet taken twice a day by mouth
Primary Outcome Measure Information:
Title
Glucose Control
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Metabolic Markers
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Niswender, MD,PHD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facility: Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16732220
Citation
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.
Results Reference
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PubMed Identifier
15768047
Citation
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.
Results Reference
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PubMed Identifier
20863707
Citation
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.
Results Reference
background
PubMed Identifier
21080630
Citation
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.
Results Reference
background
PubMed Identifier
15113738
Citation
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.
Results Reference
background
PubMed Identifier
15761181
Citation
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.
Results Reference
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PubMed Identifier
18844841
Citation
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.
Results Reference
background
PubMed Identifier
17406924
Citation
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.
Results Reference
background
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Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
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