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Completed

NCT Number: 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.

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.

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Key information

Conditions

Diabetes Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uncontrolled nutritional intervention with a supplemental beverage

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.

Placebo

Other

Primary outcomes

  1. Change in cardiometabolic statute from baseline to the end of intervention.

    Time frame: 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 outcomes

  1. Change in nutritional variables from baseline to the end of the intervention.

    Time frame: At baseline, and at the end of the intervention period (6 weeks)

    Food frequency questionnaire

  2. Change in physical activity habits from baseline to the end of the intervention.

    Time frame: ) At baseline, and at the end of the intervention period (6 weeks)

    Physical activity habits questionnaire

  3. Change in anthropometric measurements from baseline to the end of the intervention.

    Time frame: At baseline, and at the end of the intervention period (6 weeks)

    anthropometric measurements (body mass index, waist and hip circumferences)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)
  • Institute of Nutraceuticals and Functional Foods

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 11, 2013
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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