Effects of Curcumin on Vascular Reactivity

Healthy Volunteers (Middle-aged Smokers) Clinical Trial

— CURCUMIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543386
• Other study ID #: CHU-0113
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 16, 2012
• Last updated: July 4, 2014
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers (Middle-aged Smokers)

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	ARDEC Association de Recherche de Développement et d’Enseignement de la Cardiologie, Association Régionale de Cardiologie d’Auvergne, Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brachial Flow Mediated Dilatation		at Visit 1 (Day 0) and visit 2 (Day3/day5)	Yes
Secondary	Changes in fingertip arterial tonometry		at visit 1 (day 0) and visit 2 (day3/day5)	Yes
Secondary	Modifications of leukocytes transcriptome		at visit 1 (day 0) and visit 2 (day3/day 5)	Yes