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Completed

NCT Number: NCT01964846

Effect of Antioxidant Intake on Cardiovascular Risk

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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute on Nutrition and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol, curcumin

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Change in blood levels of anti- and pro-inflammatory markers

    Time frame: At the end of the two lipid tolerance tests [week0; week 2]

Secondary outcomes

  1. 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]

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Atrium Innovations

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 17, 2013
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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