Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.

L

Laval University

Status

Completed

Conditions

Diabetes
Cardiovascular Disease

Treatments

Other: Uncontrolled nutritional intervention with a supplemental beverage
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01766570
PHENOL-C11-12-155

Details and patient eligibility

About

The purpose of this study is to measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers.

Full description

Type 2 diabetes is an up rising disease that makes it a major public health problem. While 221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. It is well recognized that regular consumption of fruits and vegetables can lower the incidence of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory diseases. Recently, Drs Desjardins, Abrams and Marette's research team discovered a high amount of a sesquiterpene in berries. This molecule is recognized for its ability to improve glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese mice. The aim of this study is to determine the effect of a polyphenol rich berries extract mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin resistance.

Enrollment

60 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 40-65 year old
  • non-smoking
  • overweight (BMI>27)
  • insulin resistant (fasting insulin >90pmol/L, with fasting glycemia < 7,0 mmol/L and < 11,1 mmol/L after a 120-min oral glucose tolerance test)

Exclusion criteria

  • diabetes
  • chronic diseases
  • taking drugs that could affect glucose or lipids metabolism
  • major surgery 3 months prior to the study
  • weight variation of ±10% 6 months prior to the study
  • strawberry or cranberry allergy
  • consumption of berries rich in polyphenol and/or wine more then 3 times per week

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Phenol
Experimental group
Description:
Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix.
Treatment:
Other: Uncontrolled nutritional intervention with a supplemental beverage
Control
Placebo Comparator group
Description:
Men and women who are assigned to a 6 weeks experimental period where they consume a placebo.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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