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OpenTrials
Completed

NCT Number: NCT01575288

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

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.

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Key information

Conditions

Vascular Aging

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Boulder Clinical Translational Research Center

Boulder, Colorado, 80309, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

100g maltose 1/day

High-dose trehalose

Drug

100g 1/day

Primary outcomes

  1. Arterial Stiffness

    Time frame: 12 weeks

    Arterial pulse wave velocity

  2. nitric-oxide mediated endothelium-dependent dilation

    Time frame: 12 weeks

    flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine

Secondary outcomes

  1. Systemic oxidative stress and inflammation

    Time frame: 12 weeks

    circulating markers of oxidative stress and inflammation

  2. Endothelial cell oxidative stress and inflammation

    Time frame: 12 weeks

    inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells

  3. Insulin sensitivity

    Time frame: 12 weeks

    intravenous glucose tolerance test

  4. Endothelial cell autophagic flux

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2012
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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