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

Primary Purpose

Diabetes, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Uncontrolled nutritional intervention with a supplemental beverage
Placebo
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring insulin sensitivity,, glucose tolerance,, inflammatory markers,, lipid profile,, oxidative stress,, pancreatic β-cell function

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phenol

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in nutritional variables from baseline to the end of the intervention.
Food frequency questionnaire
Change in physical activity habits from baseline to the end of the intervention.
Physical activity habits questionnaire
Change in anthropometric measurements from baseline to the end of the intervention.
anthropometric measurements (body mass index, waist and hip circumferences)

Full Information

First Posted
October 2, 2012
Last Updated
September 1, 2015
Sponsor
Laval University
Collaborators
Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ), Institute of Nutraceuticals and Functional Foods
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1. Study Identification

Unique Protocol Identification Number
NCT01766570
Brief 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.
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ), Institute of Nutraceuticals and Functional Foods

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Cardiovascular Disease
Keywords
insulin sensitivity,, glucose tolerance,, inflammatory markers,, lipid profile,, oxidative stress,, pancreatic β-cell function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenol
Arm Type
Experimental
Arm Description
Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Men and women who are assigned to a 6 weeks experimental period where they consume a placebo.
Intervention Type
Other
Intervention Name(s)
Uncontrolled nutritional intervention with a supplemental beverage
Intervention Description
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
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in cardiometabolic statute from baseline to the end of intervention.
Description
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
Time Frame
At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Change in nutritional variables from baseline to the end of the intervention.
Description
Food frequency questionnaire
Time Frame
At baseline, and at the end of the intervention period (6 weeks)
Title
Change in physical activity habits from baseline to the end of the intervention.
Description
Physical activity habits questionnaire
Time Frame
) At baseline, and at the end of the intervention period (6 weeks)
Title
Change in anthropometric measurements from baseline to the end of the intervention.
Description
anthropometric measurements (body mass index, waist and hip circumferences)
Time Frame
At baseline, and at the end of the intervention period (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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