Effect of Antioxidant Intake on Cardiovascular Risk
|ClinicalTrials.gov Identifier: NCT01964846|
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : September 22, 2015
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 or disease||Intervention/treatment||Phase|
|Effect of Resveratrol and Curcumin on Inflammation||Dietary Supplement: Resveratrol, curcumin Dietary Supplement: Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Resveratrol and Curcumin on Postprandial Inflammation in Men and Postmenopausal Women|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2015|
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|
- Change in blood levels of anti- and pro-inflammatory markers [ Time Frame: At the end of the two lipid tolerance tests [week0; week 2] ]
- 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] ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964846
|Institute on Nutrition and Functional Foods (INAF), Laval University|
|Québec City, Quebec, Canada, G1V 0A6|
|Principal Investigator:||Charles Couillard, PhD||INAF - Université Laval|