Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
|ClinicalTrials.gov Identifier: NCT01766570|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment|
|Diabetes Cardiovascular Disease||Other: Uncontrolled nutritional intervention with a supplemental beverage Other: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 Start Date :||March 2012|
|Primary Completion Date :||September 2014|
|Study Completion Date :||August 2015|
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.
- 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
- 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
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766570
|Institute of Nutraceuticals and Functional Foods (INAF), Laval University|
|Quebec, Canada, G1V 0A6|