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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

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
Official Title  ICMJE Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vascular Aging
Intervention  ICMJE
  • Drug: Placebo
    100g maltose 1/day
  • Drug: High-dose trehalose
    100g 1/day
Study Arms  ICMJE
  • Placebo Comparator: Maltose
    Intervention: Drug: Placebo
  • Experimental: High-dose trehalose
    Intervention: Drug: High-dose trehalose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2015)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
204
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575288
Other Study ID Numbers  ICMJE B6310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Boulder
Study Sponsor  ICMJE University of Colorado, Boulder
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rachelle E Kaplon, MS University of Colorado, Denver
Principal Investigator: Douglas R Seals, PhD University of Colorado, Denver
PRS Account University of Colorado, Boulder
Verification Date December 2015

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