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

Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766570
• Other study ID #: PHENOL-C11-12-155
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: September 1, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Consortium de recherche et innovations en bioprocédés industriels au Québec
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Insulin Resistance

Intervention

Other:
• 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.
• Placebo

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functional Foods (INAF), Laval University	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ), Institute of Nutraceuticals and Functional Foods

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiometabolic statute from baseline to the end of intervention.	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	At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)	No
Secondary	Change in nutritional variables from baseline to the end of the intervention.	Food frequency questionnaire	At baseline, and at the end of the intervention period (6 weeks)	No
Secondary	Change in physical activity habits from baseline to the end of the intervention.	Physical activity habits questionnaire	) At baseline, and at the end of the intervention period (6 weeks)	No
Secondary	Change in anthropometric measurements from baseline to the end of the intervention.	anthropometric measurements (body mass index, waist and hip circumferences)	At baseline, and at the end of the intervention period (6 weeks)	No