Vascular AgingNCT01968564
Oral Curcumin Supplementation in Middle-Aged and Older Adults Improves Vascular Function
A study testing High-dose curcumin pill and Low-dose curcumin pill in people with Vascular Aging, run by University of Colorado, Boulder at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Aging
- What is being tested?
- High-dose curcumin pill and Low-dose curcumin pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder, Clinical Translational Research Center
Boulder, Colorado, 80309
About this study
Official title: 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.
- Conditions
- Vascular Aging
- Being tested
- Placebo pill, High-dose curcumin pill, Low-dose curcumin pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo pillDrug
sugar and other inert substances
High-dose curcumin pillDrug
2000mg curcumin pill/day
Low-dose curcumin pillDrug
500mg curcumin pill/day
| Study group | Role | What they receive |
|---|---|---|
| High-dose curcumin pill | Experimental | Not described Receives: Drug: High-dose curcumin pill |
| Low-dose curcumin pill | Experimental | Not described Receives: Drug: Low-dose curcumin pill |
| Placebo pill | Placebo comparator | Not described Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Arterial pulse wave velocity
Measured: 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
Measured: 12 weeks
Secondary outcomes (2)
Systemic oxidative stress and inflammation
circulating markers of oxidative stress and inflammation
Measured: 12 weeks
Endothelial cell oxidative stress and inflammation
inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Santos-Parker, MS, Study director, University of Colorado, BoulderDouglas Seals, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968564
- Sponsor's protocol ID
- B6398
- Status last verified
- Mar 2017
- First submitted
- 19 Oct 2013
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translation of Curcumin Therapy to Treat Arterial Aging
- ClinicalTrials.gov ID
- NCT01968564
- Acronym / sponsor ID
- B6398
- Conditions
- Vascular Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose curcumin pill | Experimental | Drug: High-dose curcumin pill |
| Low-dose curcumin pill | Experimental | Drug: Low-dose curcumin pill |
| Placebo pill | Placebo comparator | Drug: Placebo pill |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo pillsugar and other inert substances | Drug | Placebo pill |
| High-dose curcumin pill2000mg curcumin pill/day | Drug | High-dose curcumin pill |
| Low-dose curcumin pill500mg curcumin pill/day | Drug | Low-dose curcumin pill |
Primary outcome
Arterial Stiffness
Time frame: 12 weeks
Arterial pulse wave velocity
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
2 secondary outcomes
Systemic oxidative stress and inflammation
Time frame: 12 weeks
Endothelial cell oxidative stress and inflammation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Link Text: Description of our Research and LaboratoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Santos-Parker, MS study director
University of Colorado, Boulder
Douglas Seals, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose curcumin pill and Low-dose curcumin pill in people with Vascular Aging, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.