Clinical trial NCT01766570: Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
Official title: Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Disease
Keywords: insulin sensitivity,
glucose tolerance,
inflammatory markers,
lipid profile,
oxidative stress,
pancreatic β-cell function
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)
name: Institute of Nutraceuticals and Functional Foods
First posted: 2013-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiometabolic statute from baseline to the end of intervention.
timeFrame: At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)
Secondary outcomes:
measure: Change in nutritional variables from baseline to the end of the intervention.
timeFrame: At baseline, and at the end of the intervention period (6 weeks)
measure: Change in physical activity habits from baseline to the end of the intervention.
timeFrame: ) At baseline, and at the end of the intervention period (6 weeks)
measure: Change in anthropometric measurements from baseline to the end of the intervention.
timeFrame: At baseline, and at the end of the intervention period (6 weeks)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Study officials:
References: