Vascular AgingNCT01575288
Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
A study testing High-dose trehalose 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 a naturally occurring sugar 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… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Aging
- What is being tested?
- High-dose trehalose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2015
- 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 50 to 79 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
The proposed study will assess the ability of a naturally occurring sugar 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, High-dose trehalose
- Keywords
- arterial function, cardiovascular, aging, endothelial function, arterial stiffness, vascular function, Trehalose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
100g maltose 1/day
High-dose trehaloseDrug
100g 1/day
| Study group | Role | What they receive |
|---|---|---|
| Maltose | Placebo comparator | Not described Receives: Drug: Placebo |
| High-dose trehalose | Experimental | Not described Receives: Drug: High-dose trehalose |
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 (4)
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
Insulin sensitivity
intravenous glucose tolerance test
Measured: 12 weeks
Endothelial cell autophagic flux
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 posted11 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachelle E Kaplon, MS, Study director, University of Colorado, DenverDouglas R Seals, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575288
- Sponsor's protocol ID
- B6310
- Status last verified
- Dec 2015
- First submitted
- 6 Apr 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT01575288
- Acronym / sponsor ID
- B6310
- Conditions
- Vascular Aging
- Keywords
- arterial function, cardiovascular, aging, endothelial function, arterial stiffness, vascular function, Trehalose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Apr 2012 (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 a naturally occurring sugar 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltose | Placebo comparator | Drug: Placebo |
| High-dose trehalose | Experimental | Drug: High-dose trehalose |
Who may qualify
- Ages
- 50 to 79 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 |
|---|---|---|
| Placebo100g maltose 1/day | Drug | Maltose |
| High-dose trehalose100g 1/day | Drug | High-dose trehalose |
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
4 secondary outcomes
Systemic oxidative stress and inflammation
Time frame: 12 weeks
Endothelial cell oxidative stress and inflammation
Time frame: 12 weeks
Insulin sensitivity
Time frame: 12 weeks
Endothelial cell autophagic flux
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- 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.
Rachelle E Kaplon, MS study director
University of Colorado, Denver
Douglas R Seals, PhD principal investigator
University of Colorado, Denver
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 trehalose 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: finished, as of the sponsor's last update on 11 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 11 Dec 2015.