Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profil of Men and Women With Insulino Resistance.
This study is currently recruiting participants.
Verified January 2013 by Laval University
Sponsor:
Laval University
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: January 9, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 profil, 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 Profil of Men and Women With Insulino Resistance. |
Resource links provided by NLM:
Further study details as provided by Laval University:
Primary Outcome Measures:
- 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
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: | September 2013 |
| Estimated Primary Completion Date: | April 2013 (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 profil of obese mices. 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 profil, and oxidative stress markers, on human obese subjects that are insulino-resistant.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766570
Contacts
| Contact: Helene Jacques, Ph.D. Dt.P. | 418-656-2131 ext 3864 | helene.jacques@fsaa.ulaval.ca |
| Contact: John S Weisnagel, M.D. | 418-654-2169 | john.weisnagel@crchul.ulaval.ca |
Locations
| Canada | |
| Institute of Nutraceuticals and Functional Foods (INAF), Laval University | Recruiting |
| Quebec, Canada, G1V 0A6 | |
| Contact: Julie Marois 418-656-2131 ext 5467 julie.marois@fsaa.ulaval.ca | |
| Sub-Investigator: Helene Jacques, Ph.D Dt.P. | |
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: | January 9, 2013 |
| 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 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013