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Effect of Antioxidant Intake on Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Laval University
Sponsor:
Collaborator:
Atrium Innovations
Information provided by (Responsible Party):
Charles Couillard, Laval University
ClinicalTrials.gov Identifier:
NCT01964846
First received: October 15, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Effect of Resveratrol and Curcumin on Inflammation
Dietary Supplement: Resveratrol, curcumin
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Resveratrol and Curcumin on Postprandial Inflammation in Men and Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in blood levels of anti- and pro-inflammatory markers [ Time Frame: At the end of the two lipid tolerance tests [week0; week 2] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
n/a
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964846

Contacts
Contact: Charles Couillard, PhD 1-418-656-2131 ext 12855 charles.couillard@fsaa.ulaval.ca
Contact: Benoît Lamarche, PhD 1-418-656-2131 ext 4355 benoit.lamarche@fsaa.ulaval.ca

Locations
Canada, Quebec
Institute on Nutrition and Functional Foods (INAF), Laval University Recruiting
Québec City, Quebec, Canada, G1V 0A6
Contact: Iris Gigleux, MSc    1-418-656-2131 ext 5087    iris.gigleux@fsaa.ulaval.ca   
Contact: Marie-Eve Paradis, PhD    1-418-656-2131 ext 7492    marie-eve.paradis@fsaa.ulaval.ca   
Principal Investigator: Charles Couillard, PhD         
Principal Investigator: Benoît Lamarche, PhD         
Sub-Investigator: Patrick Couture, MD, PhD         
Sponsors and Collaborators
Laval University
Atrium Innovations
Investigators
Principal Investigator: Charles Couillard, PhD INAF - Université Laval
  More Information

No publications provided

Responsible Party: Charles Couillard, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01964846     History of Changes
Other Study ID Numbers: INAF-2013-023
Study First Received: October 15, 2013
Last Updated: October 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
inflammation
high fat meal
resveratrol
curcumin
gene expression

Additional relevant MeSH terms:
Resveratrol
Inflammation
Pathologic Processes
Curcumin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014