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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.

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

October 2, 2012
September 9, 2014
March 2012
September 2014   (final data collection date for primary outcome measure)
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
Change in cardiometabolic statute from baselin 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, hcCRP, IL-6, TNF-alpha and PAI-1 levels, triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol, HDL-cholesterol, apolipoprotein A-1 and B, oxidized-LDL, GDR, MI, beta-cells function
Complete list of historical versions of study NCT01766570 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Diabetes
  • Cardiovascular Disease
  • 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.
  • Other: Placebo
  • Experimental: Phenol
    Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix.
    Intervention: Other: Uncontrolled nutritional intervention with a supplemental beverage
  • Placebo Comparator: Control
    Men and women who are assigned to a 6 weeks experimental period where they consume a placebo.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01766570
PHENOL-C11-12-155
No
Helene Jacques, Laval University
Laval University
  • Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ)
  • Institute of Nutraceutical and Functional Foods (INAF)
Not Provided
Laval University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP