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Effect of Antioxidant Intake on Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964846
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Atrium Innovations
Information provided by (Responsible Party):
Charles Couillard, Laval University

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date September 22, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
Change in blood levels of anti- and pro-inflammatory markers [ Time Frame: At the end of the two lipid tolerance tests [week0; week 2] ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
Change in the expression of anti- and pro-inflammatory genes in total blood RNA from white blood cells (WBC) [ Time Frame: At the end of the two lipid tolerance tests [week0; week 2] ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Antioxidant Intake on Cardiovascular Risk
Official Title  ICMJE The Effect of Resveratrol and Curcumin on Postprandial Inflammation in Men and Postmenopausal Women
Brief Summary

The general objective of this project is to investigate the acute effect of consuming a dietary supplement combining resveratrol and curcumin on the inflammatory response following the consumption of a high-fat meal in healthy subjects with slightly elevated waist circumference.

The study will be undertaken according to a double-blind, cross over, randomized, placebo controlled design and will be conducted at the Institute of Nutrition and Functional Foods (INAF) of Laval University. The study will involve a total of 20 healthy subjects (10 men and 10 women. Included subjects will undergo an 6-hour oral fat tolerance, on two separate occasions (one time following dietary supplement consumption and one time following consumption of a placebo). The two test days will be separated by maximum of two weeks. The outcomes are the changes in the plasma levels of inflammatory cytokines in their gene expression.

Detailed Description

There is increasing evidence showing that inflammation is implicated in the pathogenesis of numerous chronic conditions and cardiovascular disease (CVD). Also, high-fat meals have been shown to induce postprandial oxidative stress and inflammation. Polyphenols are compounds found ubiquitously in plants and are known to regulate many processes like plant growth, reproduction, seed germination as well as resistance to pathogens and predators. They are present in fruits and vegetables and exhibit favorable physiological effects that even if they remain not fully understood, still allow the classification of phenolic compounds as antiinflammatory molecules.

Resveratrol is a polyphenol that is found in berries, grapes and red wine among others. Interest for resveratrol as a health-promoting molecule has flourished in recent years as it has been shown to prevent co-morbidities associated with diabetes and CVD. Evidence of the physiological benefits of resveratrol in humans is somewhat limited, but nonetheless supports an antiinflammatory action.

There is also an increasing body of evidence supporting the role of curcumin, a polyphenol from the curcuminoid family, as a modulator of the inflammatory pathway.These observations underline the anti-inflammatory potential of curcumin and how it may serve in the prevention and treatment of chronic conditions like diabetes and CVD.

The general objective of this project is to investigate the acute effect of consuming dietary supplement combining resveratrol and curcumin on the inflammatory response following the consumption of a high-fat meal in healthy individuals with slightly elevated waist girth.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Effect of Resveratrol and Curcumin on Inflammation
Intervention  ICMJE
  • Dietary Supplement: Resveratrol, curcumin
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Resveratrol, curcumin
    Subjects will take 2 capsules of resveratrol and curcumin. Thirty (30) minutes later, subjects will be given an oral lipid tolerance test in the form of a fat-rich meal. Blood samples will be collected at different time points.
    Intervention: Dietary Supplement: Resveratrol, curcumin
  • Placebo Comparator: Placebo
    Subjects will take 2 capsules of Placebo. Thirty (30) minutes later, subjects will be given an oral lipid tolerance test in the form of a fat-rich meal. Blood samples will be collected at different time points.
    Intervention: Dietary Supplement: Placebo
Publications * Vors C, Couillard C, Paradis ME, Gigleux I, Marin J, Vohl MC, Couture P, Lamarche B. Supplementation with Resveratrol and Curcumin Does Not Affect the Inflammatory Response to a High-Fat Meal in Older Adults with Abdominal Obesity: A Randomized, Placebo-Controlled Crossover Trial. J Nutr. 2018 Mar 1;148(3):379-388. doi: 10.1093/jn/nxx072.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2013)
20
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and postmenopausal women aged between 45-70 years
  • When applicable, menopause will be defined as the absence of menses for at least 1 year
  • Weight stable (for at least three (3) months)
  • Otherwise healthy individuals
  • No medication
  • Waist circumference >=94 cm for men or >=80 cm for women
  • With one (and no more than one) of the following:
  • triglycerides >=1.7 mmol/L
  • HDL-c <=1.03 mmol/L for men and <=1.29 mmol/L for women
  • fasting glucose >=5.6 mmol/L
  • systolic blood pressure >=130 or diastolic blood pressure >=85 mmHg

Exclusion Criteria:

  • Diagnosis of hypertension, CVD, T2D or endocrine disorders
  • Aversion/intolerance to spice
  • ≥ 3 risk factors for the metabolic syndrome (IDF)
  • Fasting triglycerides > 4 mmol/L
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964846
Other Study ID Numbers  ICMJE INAF-2013-023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Charles Couillard, Laval University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Laval University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Atrium Innovations
Investigators  ICMJE
Principal Investigator: Charles Couillard, PhD INAF - Université Laval
PRS Account Laval University
Verification Date September 2015

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