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

March 17, 2017 updated by: University of Colorado, Boulder

Clinical Translation of Curcumin Therapy to Treat Arterial Aging

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder, Clinical Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo pill
Drug: Placebo pill
sugar and other inert substances
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Stiffness
Time Frame: 12 weeks
Arterial pulse wave velocity
12 weeks
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic oxidative stress and inflammation
Time Frame: 12 weeks
circulating markers of oxidative stress and inflammation
12 weeks
Endothelial cell oxidative stress and inflammation
Time Frame: 12 weeks
inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Investigators

  • Study Director: Jessica Santos-Parker, MS, University of Colorado, Boulder
  • Principal Investigator: Douglas Seals, PhD, University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

October 19, 2013

First Submitted That Met QC Criteria

October 19, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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