Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
This study is currently recruiting participants.
Verified December 2012 by University of Colorado, Boulder
Sponsor:
University of Colorado, Boulder
Information provided by (Responsible Party):
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT01575288
First received: April 6, 2012
Last updated: December 31, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vascular Aging |
Drug: Placebo Drug: Low-dose trehalose Drug: High-dose trehalose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Boulder:
Primary Outcome Measures:
- Arterial Stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Arterial pulse wave velocity
- nitric-oxide mediated endothelium-dependent dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine
Secondary Outcome Measures:
- Systemic oxidative stress and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]circulating markers of oxidative stress and inflammation
- Endothelial cell oxidative stress and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells
- Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]intravenous glucose tolerance test
- Endothelial cell autophagic flux [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 204 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Maltose |
Drug: Placebo
100g maltose 1/day
|
| Experimental: Low-dose trehalose |
Drug: Low-dose trehalose
50g maltose and 50g trehalose 1/day
|
| Experimental: High-dose trehalose |
Drug: High-dose trehalose
100g 1/day
|
Eligibility| Ages Eligible for Study: | 50 Years to 79 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575288
Contacts
| Contact: Molly J Russell, MS | 303-492-2485 | cvstudy@colorado.edu |
| Contact: Rachelle E Kaplon, MS | 303-492-4568 | rachelle.kaplon@colorado.edu |
Locations
| United States, Colorado | |
| University of Colorado, Boulder Clinical Translational Research Center | Recruiting |
| Boulder, Colorado, United States, 80309 | |
| Contact: Molly J Russell, MS 303-492-2485 cvstudy@colorado.edu | |
| Principal Investigator: Douglas R Seals, Phd | |
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
| Study Director: | Rachelle E Kaplon, MS | University of Colorado, Denver |
| Principal Investigator: | Douglas R Seals, PhD | University of Colorado, Denver |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Colorado, Boulder |
| ClinicalTrials.gov Identifier: | NCT01575288 History of Changes |
| Other Study ID Numbers: | B6310 |
| Study First Received: | April 6, 2012 |
| Last Updated: | December 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Boulder:
|
arterial function cardiovascular aging endothelial function |
arterial stiffness vascular function Trehalose |
Additional relevant MeSH terms:
|
Mycoses |
ClinicalTrials.gov processed this record on May 16, 2013