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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Diabetes
• Interventions: Other: Uncontrolled nutritional intervention with a supplemental beverage; Other: Placebo

• Registration Number: NCT01766570
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2014-09
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in cardiometabolic statute from baseline to the end of intervention.	At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)	glucose and insulin concentrations during a 120-min euglycemic-hyperinsulinemic clamp, glucose and insulin concentrations during a 120-min oral glucose tolerance test, insulin sensitivity, c-peptide, C-reactive protein (hs-CRP), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and plasminogen activator inhibitor-1 (PAI-1) levels, triglycerides, total cholesterol, very low density lipoprotein cholesterol (cVLDL), low density lipoprotein cholesterol (cLDL), high density lipoprotein cholesterol (cHDL), apolipoprotein A-1 and B, oxidized-LDL, glucose disposition rate (GDR), insulin sensitivity measure (MI), beta-cells function

Secondary Outcome Measures

Name	Time	Method
Change in anthropometric measurements from baseline to the end of the intervention.	At baseline, and at the end of the intervention period (6 weeks)	anthropometric measurements (body mass index, waist and hip circumferences)
Change in physical activity habits from baseline to the end of the intervention.	) At baseline, and at the end of the intervention period (6 weeks)	Physical activity habits questionnaire
Change in nutritional variables from baseline to the end of the intervention.	At baseline, and at the end of the intervention period (6 weeks)	Food frequency questionnaire

Trial Locations

Locations (1)

Institute of Nutraceuticals and Functional Foods (INAF), Laval University; 🇨🇦 Quebec, Canada