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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Boulder
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT01575288
First received: April 6, 2012
Last updated: May 19, 2014
Last verified: May 2014

April 6, 2012
May 19, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
  • Arterial Stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Arterial pulse wave velocity
  • nitric-oxide mediated endothelium-dependent dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    circulating markers of oxidative stress and inflammation
  • Endothelial cell oxidative stress and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    intravenous glucose tolerance test
  • Endothelial cell autophagic flux [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
124
September 2015
May 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
Both
50 Years to 79 Years
Yes
Contact: Molly J Russell, MS 303-492-2485 cvstudy@colorado.edu
Contact: Rachelle E Kaplon, MS 303-492-4568 rachelle.kaplon@colorado.edu
United States
 
NCT01575288
B6310
Yes
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
May 2014

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