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Effects of Curcumin on Vascular Reactivity (CURCUMIN)

This study is currently recruiting participants.
Verified July 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Institut National de la Recherche Agronomique
Association Régionale de Cardiologie d’Auvergne
ARDEC Association de Recherche de Développement et d’Enseignement de la Cardiologie
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01543386
First received: February 16, 2012
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers (Middle-aged Smokers)
 Drug: Curcumin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers

Resource links provided by NLM:

Drug Information available for: Curcumin
U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Changes in brachial Flow Mediated Dilatation [ Time Frame: at Visit 1 (Day 0) and visit 2 (Day3/day5) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in fingertip arterial tonometry [ Time Frame: at visit 1 (day 0) and visit 2 (day3/day5) ] [ Designated as safety issue: Yes ]
  • Modifications of leukocytes transcriptome [ Time Frame: at visit 1 (day 0) and visit 2 (day3/day 5) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: February 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 to 70 year-old volunteers
  • smokers

Exclusion Criteria:

  • treated hypertension
  • treated hypercholesterolemia
  • chronic disease
  • vegetarian or other unusual diets
  • chronic alcoholism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543386

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Institut National de la Recherche Agronomique
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
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01543386     History of Changes
Other Study ID Numbers: CHU-0113
Study First Received: February 16, 2012
Last Updated: July 13, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Polyphenol
Curcumin
Endothelium, vascular
 Endothelium-dependant relaxing factor
Smoking
Transcriptome

Additional relevant MeSH terms:
Curcumin
Endothelium-Dependent Relaxing Factors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013