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

NCT01766570 | Completed

• 1 other identifier: PHENOL-C11-12-155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Cardiovascular Disease

Keywords

insulin sensitivity,; glucose tolerance,; inflammatory markers,; lipid profile,; oxidative stress,; pancreatic β-cell function

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)

Secondary Outcomes (3)

• Change in nutritional variables from baseline to the end of the intervention.

  At baseline, and at the end of the intervention period (6 weeks)

• Change in physical activity habits from baseline to the end of the intervention.

  ) At baseline, and at the end of the intervention period (6 weeks)

• Change in anthropometric measurements from baseline to the end of the intervention.

  At baseline, and at the end of the intervention period (6 weeks)

Study Arms (2)

Phenol

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Uncontrolled nutritional intervention with a supplemental beverage OTHER

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.

Phenol

Placebo OTHER

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ): collaborator
• Institute of Nutraceuticals and Functional Foods: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: January 11, 2013
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

CA (1)