NCT01964846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

October 15, 2013

Last Update Submit

September 21, 2015

Conditions

Effect of Resveratrol and Curcumin on Inflammation

Keywords

inflammationhigh fat mealresveratrolcurcumingene expression

Outcome Measures

Primary Outcomes (1)

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

    At the end of the two lipid tolerance tests [week0; week 2]

Secondary Outcomes (1)

  • 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]

Study Arms (2)

Resveratrol, curcumin

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Resveratrol, curcuminDIETARY_SUPPLEMENT
Resveratrol, curcumin
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29546309DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

ResveratrolCurcumin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicCatechols

Study Officials

  • Charles Couillard, PhD

    INAF - Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 17, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

CA(1)