Effect of Antioxidant Intake on Cardiovascular Risk

NCT ID: NCT01964846

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-03-31

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.

Conditions

Effect of Resveratrol and Curcumin on Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resveratrol, curcumin

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Resveratrol, curcumin

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atrium Innovations

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Charles Couillard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Couillard, PhD

Role: PRINCIPAL_INVESTIGATOR

INAF - Université Laval

Locations

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

Québec, Quebec, Canada

Countries

Canada

References

Vors C, Couillard C, Paradis ME, Gigleux I, Marin J, Vohl MC, Couture P, Lamarche B. Supplementation with Resveratrol and Curcumin Does Not Affect the Inflammatory Response to a High-Fat Meal in Older Adults with Abdominal Obesity: A Randomized, Placebo-Controlled Crossover Trial. J Nutr. 2018 Mar 1;148(3):379-388. doi: 10.1093/jn/nxx072.

Reference Type: DERIVED

PMID: 29546309 (View on PubMed)

Other Identifiers

INAF-2013-023

Identifier Type: -

Identifier Source: org_study_id