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Effect of Antioxidant Intake on Cardiovascular Risk

Primary Purpose

Effect of Resveratrol and Curcumin on Inflammation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resveratrol, curcumin
Placebo
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Effect of Resveratrol and Curcumin on Inflammation focused on measuring inflammation, high fat meal, resveratrol, curcumin, gene expression

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol, curcumin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the expression of anti- and pro-inflammatory genes in total blood RNA from white blood cells (WBC)

Full Information

First Posted
October 15, 2013
Last Updated
September 21, 2015
Sponsor
Laval University
Collaborators
Atrium Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT01964846
Brief Title
Effect of Antioxidant Intake on Cardiovascular Risk
Official Title
The Effect of Resveratrol and Curcumin on Postprandial Inflammation in Men and Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Atrium Innovations

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Resveratrol and Curcumin on Inflammation
Keywords
inflammation, high fat meal, resveratrol, curcumin, gene expression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol, curcumin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol, curcumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Couillard, PhD
Organizational Affiliation
INAF - Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute on Nutrition and Functional Foods (INAF), Laval University
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29546309
Citation
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.
Results Reference
derived

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Effect of Antioxidant Intake on Cardiovascular Risk

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