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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01575288

Enrollment

110

Registered

2012-04-11

Start date

2012-05-31

Completion date

2015-12-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Aging

Keywords

arterial function, cardiovascular, aging, endothelial function, arterial stiffness, vascular function, Trehalose

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.

Interventions

DRUGPlacebo

100g maltose 1/day

DRUGHigh-dose trehalose

100g 1/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026