Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)
Institute of Nutraceutical and Functional Foods (INAF)
Information provided by (Responsible Party):
Helene Jacques, Laval University
ClinicalTrials.gov Identifier:
NCT01766570
First received: October 2, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes
Cardiovascular Disease
Other: Uncontrolled nutritional intervention with a supplemental beverage
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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. [ Time Frame: At baseline, and at the end of the intervention period (6 weeks) ] [ Designated as safety issue: No ]
    Food frequency questionnaire

  • 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) ] [ Designated as safety issue: No ]
    Physical activity habits questionnaire

  • 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) ] [ Designated as safety issue: No ]
    anthropometric measurements (body mass index, waist and hip circumferences)


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenol
Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix.
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 Comparator: Control
Men and women who are assigned to a 6 weeks experimental period where they consume a placebo.
Other: Placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766570

Locations
Canada
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)
Institute of Nutraceutical and Functional Foods (INAF)
  More Information

No publications provided

Responsible Party: Helene Jacques, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01766570     History of Changes
Other Study ID Numbers: PHENOL-C11-12-155
Study First Received: October 2, 2012
Last Updated: September 9, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Consortium de recherche et innovations en bioprocédés industriels au Québec

Keywords provided by Laval University:
insulin sensitivity,
glucose tolerance,
inflammatory markers,
lipid profile,
oxidative stress,
pancreatic β-cell function

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014