Effects of Curcumin on Vascular Reactivity (CURCUMIN)

This study has been completed.
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 4, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 21
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543386

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
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 4, 2014
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 October 01, 2014