Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults

Vascular Aging Clinical Trial

Official title:

Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575288
• Other study ID #: B6310
• Status: Completed
• Phase: N/A
• First received: April 6, 2012
• Last updated: December 9, 2015
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Aging

Intervention

Drug:
• Placebo
100g maltose 1/day
• High-dose trehalose
100g 1/day

Locations

Country	Name	City	State
United States	University of Colorado, Boulder Clinical Translational Research Center	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Stiffness	Arterial pulse wave velocity	12 weeks	No
Primary	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	12 weeks	No
Secondary	Systemic oxidative stress and inflammation	circulating markers of oxidative stress and inflammation	12 weeks	No
Secondary	Endothelial cell oxidative stress and inflammation	inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells	12 weeks	No
Secondary	Insulin sensitivity	intravenous glucose tolerance test	12 weeks	No
Secondary	Endothelial cell autophagic flux		12 weeks	No

External Links

•   Description of our Research and Laboratory