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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01968564
Other study ID # B6398
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 19, 2013
Last updated March 17, 2017
Start date June 2013
Est. completion date June 2017

Study information

Verified date March 2017
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study will assess the ability of curcumin, the active ingredient in the Indian spice tumeric, to improve the function of arteries with age. Overall, the proposed research project has the long-term potential to influence clinical practice guidelines by establishing a novel, easy to deliver, cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 118
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- women must be postmenopausal

- body mass index (BMI) <40 kg/m2

- weight stable in the prior 3 months

- absence of clinical disease as determined by medical history, physical examination, blood and urine chemistries, ankle-brachial index, and a graded exercise stress test with monitoring of blood pressure and 12-lead ECG

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo pill
sugar and other inert substances
High-dose curcumin pill
2000mg curcumin pill/day
Low-dose curcumin pill
500mg curcumin pill/day

Locations

Country Name City State
United States University of Colorado Boulder, Clinical Translational Research Center Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial Stiffness Arterial pulse wave velocity 12 weeks
Primary Nitric-oxide mediated endothelium-dependent dilation flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine 12 weeks
Secondary Systemic oxidative stress and inflammation circulating markers of oxidative stress and inflammation 12 weeks
Secondary Endothelial cell oxidative stress and inflammation inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells 12 weeks
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