Polyphenols and Insulin Resistance

Healthy Volunteers Clinical Trial

— POLYOXRESIST  

Official title:

INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478841
• Other study ID #: UF8178
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: February 10, 2012
• Start date: October 2008
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Absence of anti HIV or anti hepatitis C antibodies and of HBS antigen.

• Acceptable biological assessment of the hepatic and renal functions (?GT, 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy Volunteers
• Insulin Resistance
• Type 2 Diabetes (T2D)

Intervention

Drug:
• polyphenol
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
• placebo
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

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral insulin-sensitivity		6 weeks	No
Secondary	biochemical parameters		6 weeks	No