NCT01543386

Brief Summary

The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1

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

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

February 16, 2012

Last Update Submit

July 4, 2014

Conditions

Keywords

PolyphenolCurcuminEndothelium, vascularEndothelium-dependant relaxing factorSmokingTranscriptome

Outcome Measures

Primary Outcomes (1)

  • Changes in brachial Flow Mediated Dilatation

    at Visit 1 (Day 0) and visit 2 (Day3/day5)

Secondary Outcomes (2)

  • Changes in fingertip arterial tonometry

    at visit 1 (day 0) and visit 2 (day3/day5)

  • Modifications of leukocytes transcriptome

    at visit 1 (day 0) and visit 2 (day3/day 5)

Study Arms (1)

curcumin

OTHER

The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Drug: Curcumin

Interventions

The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

curcumin

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 year-old volunteers
  • smokers

You may not qualify if:

  • treated hypertension
  • treated hypercholesterolemia
  • chronic disease
  • vegetarian or other unusual diets
  • chronic alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Barber-Chamoux N, Milenkovic D, Verny MA, Habauzit V, Pereira B, Lambert C, Richard D, Boby C, Mazur A, Lusson JR, Dubray C, Morand C. Substantial Variability Across Individuals in the Vascular and Nutrigenomic Response to an Acute Intake of Curcumin: A Randomized Controlled Trial. Mol Nutr Food Res. 2018 Mar;62(5). doi: 10.1002/mnfr.201700418. Epub 2018 Feb 12.

MeSH Terms

Conditions

Smoking

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Jean-René LUSSON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 5, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations