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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01575288
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):

April 6, 2012
April 11, 2012
December 11, 2015
May 2012
December 2015   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01575288 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Not Provided
Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vascular Aging
  • Drug: Placebo
    100g maltose 1/day
  • Drug: High-dose trehalose
    100g 1/day
  • Placebo Comparator: Maltose
    Intervention: Drug: Placebo
  • Experimental: High-dose trehalose
    Intervention: Drug: High-dose trehalose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 79 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Colorado, Boulder
University of Colorado, Boulder
Not Provided
Study Director: Rachelle E Kaplon, MS University of Colorado, Denver
Principal Investigator: Douglas R Seals, PhD University of Colorado, Denver
University of Colorado, Boulder
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP