Effect of Antioxidant Intake on Cardiovascular Risk

Effect of Resveratrol and Curcumin on Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964846
• Other study ID #: INAF-2013-023
• Status: Completed
• Phase: N/A
• First received: October 15, 2013
• Last updated: September 21, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Effect of Resveratrol and Curcumin on Inflammation
• Inflammation

Intervention

Dietary Supplement:
• Resveratrol, curcumin

• Placebo

Locations

Country	Name	City	State
Canada	Institute on Nutrition and Functional Foods (INAF), Laval University	Québec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Atrium Innovations

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood levels of anti- and pro-inflammatory markers		At the end of the two lipid tolerance tests [week0; week 2]	No
Secondary	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]	No