Effects of Curcumin on Vascular Reactivity (CURCUMIN)

July 4, 2014 updated by: University Hospital, Clermont-Ferrand

Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50 to 70 year-old volunteers
  • smokers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: curcumin
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in brachial Flow Mediated Dilatation
Time Frame: at Visit 1 (Day 0) and visit 2 (Day3/day5)
at Visit 1 (Day 0) and visit 2 (Day3/day5)

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in fingertip arterial tonometry
Time Frame: at visit 1 (day 0) and visit 2 (day3/day5)
at visit 1 (day 0) and visit 2 (day3/day5)
Modifications of leukocytes transcriptome
Time Frame: at visit 1 (day 0) and visit 2 (day3/day 5)
at visit 1 (day 0) and visit 2 (day3/day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Association Régionale de Cardiologie d'Auvergne
ARDEC Association de Recherche de Développement et d'Enseignement de la Cardiologie

Investigators

  • Principal Investigator: Jean-René LUSSON, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (ESTIMATE)

March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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