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

This study is currently recruiting participants.
Verified December 2012 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: December 31, 2012
Last verified: December 2012
  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: Low-dose trehalose
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: 204
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: Low-dose trehalose Drug: Low-dose trehalose
50g maltose and 50g trehalose 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
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: December 31, 2012
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 April 16, 2014