Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
University of Colorado, Boulder Identifier:
First received: April 6, 2012
Last updated: December 9, 2015
Last verified: December 2015
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.

Condition Intervention
Vascular Aging
Drug: Placebo
Drug: High-dose trehalose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults

Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • Arterial Stiffness [ Time Frame: 12 weeks ]
    Arterial pulse wave velocity

  • 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 Outcome Measures:
  • Systemic oxidative stress and inflammation [ Time Frame: 12 weeks ]
    circulating markers of oxidative stress and inflammation

  • Endothelial cell oxidative stress and inflammation [ Time Frame: 12 weeks ]
    inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells

  • Insulin sensitivity [ Time Frame: 12 weeks ]
    intravenous glucose tolerance test

  • Endothelial cell autophagic flux [ Time Frame: 12 weeks ]

Enrollment: 110
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Maltose Drug: Placebo
100g maltose 1/day
Experimental: High-dose trehalose Drug: High-dose trehalose
100g 1/day


Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01575288

United States, Colorado
University of Colorado, Boulder Clinical Translational Research Center
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Study Director: Rachelle E Kaplon, MS University of Colorado, Denver
Principal Investigator: Douglas R Seals, PhD University of Colorado, Denver
  More Information

Additional Information:
Responsible Party: University of Colorado, Boulder Identifier: NCT01575288     History of Changes
Other Study ID Numbers: B6310
Study First Received: April 6, 2012
Last Updated: December 9, 2015

Keywords provided by University of Colorado, Boulder:
arterial function
endothelial function
arterial stiffness
vascular function
Trehalose processed this record on May 23, 2017