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

Not Applicable

Completed

• Conditions: Vascular Aging
• Interventions: Drug: Placebo; Drug: High-dose trehalose

• Registration Number: NCT01575288
• Lead Sponsor: University of Colorado, Boulder

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Study Start: 2012-05
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltose	Placebo	-
High-dose trehalose	High-dose trehalose	-

Primary Outcome Measures

Name	Time	Method
Arterial Stiffness	12 weeks	Arterial pulse wave velocity
nitric-oxide mediated endothelium-dependent dilation	12 weeks	flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine

Secondary Outcome Measures

Name	Time	Method
Endothelial cell autophagic flux	12 weeks
Systemic oxidative stress and inflammation	12 weeks	circulating markers of oxidative stress and inflammation
Insulin sensitivity	12 weeks	intravenous glucose tolerance test
Endothelial cell oxidative stress and inflammation	12 weeks	inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells

Trial Locations

Locations (1)

University of Colorado, Boulder Clinical Translational Research Center; 🇺🇸 Boulder, Colorado, United States