Effect of Antioxidant Intake on Cardiovascular Risk

Not Applicable

Completed

• Conditions: Effect of Resveratrol and Curcumin on Inflammation
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Resveratrol, curcumin

• Registration Number: NCT01964846
• Lead Sponsor: Laval University

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Primary Completion: 2014-03
• Study Completion: 2015-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Resveratrol, curcumin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in the expression of anti- and pro-inflammatory genes in total blood RNA from white blood cells (WBC)	At the end of the two lipid tolerance tests [week0; week 2]

Trial Locations

Locations (1)

Institute on Nutrition and Functional Foods (INAF), Laval University; 🇨🇦 Québec City, Quebec, Canada