Polyphenols and Insulin Resistance

NCT01478841 | Completed DMC

• 1 other identifier: UF8178
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Peripheral insulin-sensitivity

  6 weeks

Secondary Outcomes (1)

• biochemical parameters

  6 weeks

Study Arms (2)

Polyphenols

EXPERIMENTAL

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).

Drug: polyphenol

placebo

PLACEBO COMPARATOR

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).

Drug: placebo

Interventions

polyphenol DRUG

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

Polyphenols

placebo DRUG

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Hyperthermia (T°\>38°c)
• Subject deprived of freedom by a court or administrative order
• Major protected by the law
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 23275372 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2012
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

FR (1)