Effect of Antioxidant Intake on Cardiovascular Risk

September 21, 2015 updated by: Charles Couillard, Laval University

The Effect of Resveratrol and Curcumin on Postprandial Inflammation in Men and Postmenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec City, Quebec, Canada, G1V 0A6
        • Institute on Nutrition and Functional Foods (INAF), Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood levels of anti- and pro-inflammatory markers
Time Frame: At the end of the two lipid tolerance tests [week0; week 2]
At the end of the two lipid tolerance tests [week0; week 2]

Secondary Outcome Measures

Outcome Measure
Time Frame
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]
At the end of the two lipid tolerance tests [week0; week 2]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Atrium Innovations

Investigators

  • Principal Investigator: Charles Couillard, PhD, INAF - Université Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INAF-2013-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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