Back to resultsPolyphenols and Insulin Resistance (POLYOXRESIST)
Primary Purpose
Healthy Volunteers, Insulin Resistance, Type 2 Diabetes (T2D)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polyphenol
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers focused on measuring insulin resistance, type 2 diabetes (T2D), cardiovascular complications, polyphenolic compounds derived from red grape marc extracts, oxidative stress
Eligibility Criteria
Inclusion Criteria:
- Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
- Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
- Age between 30 and 55 years.
- Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
- No regular physical activity (Voorips index < 9)
- Absence of any drug treatment in progress and during the last 2 months
- Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement >94 cm for males, and >80 cm for females.
- Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
- Normal ferritin level (75 - 300 ng/ml)
- hs-CRP <8 mg/l.
- Absence of arterial hypertension (systolic pressure <140 mmHg and diastolic pressure <90 mmHg).
- Non smoker or former smoker (quit smoking >1 year).
- Alcohol consumption <30 g/day.
Exclusion Criteria:
- Hyperthermia (T°>38°c)
- Subject deprived of freedom by a court or administrative order
- Major protected by the law
- Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
- Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
- Subject who cannot be subjected to muscle biopsy.
- Allergy to the anaesthetic
- Woman in age to procreate and not taking any oral or intra-uterine contraception
Sites / Locations
- Montpellier University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyphenols
placebo
Arm Description
9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63).
9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63).
Outcomes
Primary Outcome Measures
Peripheral insulin-sensitivity
Secondary Outcome Measures
biochemical parameters
Full Information
NCT ID
NCT01478841
First Posted
November 21, 2011
Last Updated
February 10, 2012
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01478841
Brief Title
Polyphenols and Insulin Resistance
Acronym
POLYOXRESIST
Official Title
INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Insulin Resistance, Type 2 Diabetes (T2D)
Keywords
insulin resistance, type 2 diabetes (T2D), cardiovascular complications, polyphenolic compounds derived from red grape marc extracts, oxidative stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyphenols
Arm Type
Experimental
Arm Description
9 weeks of supplementation with polyphenols(D56) and during the last week supplementation with polyphenols associated with a fructose load during the last 6 days (D63).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
9 weeks of supplementation with placebo (D56) and during the last week supplementation with placebo associated with a fructose load during the last 6 days (D63).
Intervention Type
Drug
Intervention Name(s)
polyphenol
Intervention Description
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
Primary Outcome Measure Information:
Title
Peripheral insulin-sensitivity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
biochemical parameters
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.
Acceptable biological assessment of the hepatic and renal functions (γGT, ALAT, ASAT < 3 times the normal value and serum creatinine <150 micromol/l).
Age between 30 and 55 years.
Fasting plasma glucose <110 mg/dl and absence of any anti-diabetic treatment
No regular physical activity (Voorips index < 9)
Absence of any drug treatment in progress and during the last 2 months
Subjects with at least one 1st degree relative with T2D and with a body mass index between 25 and 35 kg/m² and a waist measurement >94 cm for males, and >80 cm for females.
Normal ionogram (sodium 135 - 145 mmol/l, potassium 3,5 - 4,5 mmol/l).
Normal ferritin level (75 - 300 ng/ml)
hs-CRP <8 mg/l.
Absence of arterial hypertension (systolic pressure <140 mmHg and diastolic pressure <90 mmHg).
Non smoker or former smoker (quit smoking >1 year).
Alcohol consumption <30 g/day.
Exclusion Criteria:
Hyperthermia (T°>38°c)
Subject deprived of freedom by a court or administrative order
Major protected by the law
Subject who is in a period of relative exclusion due to his/her participation to another protocol or for whom the annual maximum amount of allowances of 3 811.23 € is reached.
Subject who has been treated with anti-coagulants, anti-inflammatory drugs, b-blockers or insulin during the last month.
Subject who cannot be subjected to muscle biopsy.
Allergy to the anaesthetic
Woman in age to procreate and not taking any oral or intra-uterine contraception
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23275372
Citation
Hokayem M, Blond E, Vidal H, Lambert K, Meugnier E, Feillet-Coudray C, Coudray C, Pesenti S, Luyton C, Lambert-Porcheron S, Sauvinet V, Fedou C, Brun JF, Rieusset J, Bisbal C, Sultan A, Mercier J, Goudable J, Dupuy AM, Cristol JP, Laville M, Avignon A. Grape polyphenols prevent fructose-induced oxidative stress and insulin resistance in first-degree relatives of type 2 diabetic patients. Diabetes Care. 2013 Jun;36(6):1454-61. doi: 10.2337/dc12-1652. Epub 2012 Dec 28.
Results Reference
derived
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Polyphenols and Insulin Resistance
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