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Effects of Curcumin on Vascular Reactivity (CURCUMIN)

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ClinicalTrials.gov Identifier: NCT01543386
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : July 8, 2014
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

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

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

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  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers
Study Start Date : February 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Changes in brachial Flow Mediated Dilatation [ Time Frame: at Visit 1 (Day 0) and visit 2 (Day3/day5) ]

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


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01543386     History of Changes
Other Study ID Numbers: CHU-0113
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

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
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents