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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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Vascular Aging Drug: Placebo Drug: High-dose trehalose Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
Study Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Maltose Drug: Placebo
100g maltose 1/day
Experimental: High-dose trehalose Drug: High-dose trehalose
100g 1/day


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

  2. 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 :
  1. Systemic oxidative stress and inflammation [ Time Frame: 12 weeks ]
    circulating markers of oxidative stress and inflammation

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

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

  4. Endothelial cell autophagic flux [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575288


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

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Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT01575288    
Other Study ID Numbers: B6310
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by University of Colorado, Boulder:
arterial function
cardiovascular
aging
endothelial function
 arterial stiffness
vascular function
Trehalose