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

University of Colorado Boulder (CU)

Status: Completed

Conditions: Vascular Aging

Treatments: Drug: Placebo; Drug: High-dose trehalose

Study type: Interventional

Funder types: Other

Identifiers

NCT01575288

B6310

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Maltose

Placebo Comparator group

Treatment:

Drug: Placebo

High-dose trehalose

Experimental group

Treatment:

Drug: High-dose trehalose