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

NCT ID: NCT01766570

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Diabetes; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Phenol

Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix.

Group Type: EXPERIMENTAL

Uncontrolled nutritional intervention with a supplemental beverage

Intervention Type: OTHER

Men and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content.

Control

Men and women who are assigned to a 6 weeks experimental period where they consume a placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Uncontrolled nutritional intervention with a supplemental beverage

Men and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content.

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)

UNKNOWN

Sponsor Role: collaborator

Institute of Nutraceuticals and Functional Foods

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Helene Jacques

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

PHENOL-C11-12-155

Identifier Type: -

Identifier Source: org_study_id