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Oral Curcumin Supplementation in Middle-Aged and Older Adults Improves Vascular Function

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ClinicalTrials.gov Identifier: NCT01968564
Recruitment Status : Unknown
Verified March 2017 by University of Colorado, Boulder.
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2013
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Vascular Aging Drug: Placebo pill Drug: High-dose curcumin pill Drug: Low-dose curcumin pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Translation of Curcumin Therapy to Treat Arterial Aging
Study Start Date : June 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: High-dose curcumin pill Drug: High-dose curcumin pill
2000mg curcumin pill/day

Experimental: Low-dose curcumin pill Drug: Low-dose curcumin pill
500mg curcumin pill/day

Placebo Comparator: Placebo pill Drug: Placebo pill
sugar and other inert substances




Primary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: 12 weeks ]
    Arterial pulse wave velocity

  2. Nitric-oxide mediated endothelium-dependent dilation [ Time Frame: 12 weeks ]
    flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine


Secondary Outcome Measures :
  1. Systemic oxidative stress and inflammation [ Time Frame: 12 weeks ]
    circulating markers of oxidative stress and inflammation

  2. Endothelial cell oxidative stress and inflammation [ Time Frame: 12 weeks ]
    inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01968564


Locations
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United States, Colorado
University of Colorado Boulder, Clinical Translational Research Center
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
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Study Director: Jessica Santos-Parker, MS University of Colorado, Boulder
Principal Investigator: Douglas Seals, PhD University of Colorado, Boulder

Additional Information:
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Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01968564     History of Changes
Other Study ID Numbers: B6398
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Enzyme Inhibitors
Curcumin
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
Molecular Mechanisms of Pharmacological Action