Oral Curcumin Supplementation in Middle-Aged and Older Adults Improves Vascular Function
Clinical Translation of Curcumin Therapy to Treat Arterial Aging
1 other identifier
interventional
118
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 19, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 20, 2017
March 1, 2017
4 years
October 19, 2013
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Arterial Stiffness
Arterial pulse wave velocity
12 weeks
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 Outcomes (2)
Systemic oxidative stress and inflammation
12 weeks
Endothelial cell oxidative stress and inflammation
12 weeks
Study Arms (3)
High-dose curcumin pill
EXPERIMENTALLow-dose curcumin pill
EXPERIMENTALPlacebo pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Boulder, Clinical Translational Research Center
Boulder, Colorado, 80309, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessica Santos-Parker, MS
University of Colorado, Boulder
- PRINCIPAL INVESTIGATOR
Douglas Seals, PhD
University of Colorado, Boulder
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2013
First Posted
October 24, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 20, 2017
Record last verified: 2017-03