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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 124
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT01575288

Contacts
Contact: Molly J Russell, MS 303-492-2485 cvstudy@colorado.edu
Contact: Rachelle E Kaplon, MS 303-492-4568 rachelle.kaplon@colorado.edu

Locations
United States, Colorado
University of Colorado, Boulder Clinical Translational Research Center Recruiting
Boulder, Colorado, United States, 80309
Contact: Molly J Russell, MS    303-492-2485    cvstudy@colorado.edu   
Principal Investigator: Douglas R Seals, Phd         
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
Study Director: Rachelle E Kaplon, MS University of Colorado, Denver
Principal Investigator: Douglas R Seals, PhD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01575288     History of Changes
Other Study ID Numbers: B6310
Study First Received: April 6, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Boulder:
arterial function
cardiovascular
aging
endothelial function
arterial stiffness
vascular function
Trehalose

Additional relevant MeSH terms:
Mycoses

ClinicalTrials.gov processed this record on August 21, 2014