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

• ClinicalTrials.gov Identifier: NCT01575288
• Recruitment Status: Completed
• First Posted: April 11, 2012
• Last Update Posted: December 11, 2015
• Sponsor: University of Colorado, Boulder
• Information provided by (Responsible Party): University of Colorado, Boulder

Tracking Information

• First Submitted Date: April 6, 2012
• First Posted Date: April 11, 2012
• Last Update Posted Date: December 11, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Vascular Aging

Intervention

• Drug: Placebo
  100g maltose 1/day
• Drug: High-dose trehalose
  100g 1/day

Study Arms

• Placebo Comparator: Maltose
  Intervention: Drug: Placebo
• Experimental: High-dose trehalose
  Intervention: Drug: High-dose trehalose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 9, 2015): 110
• Original Estimated Enrollment (submitted: April 9, 2012): 204
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01575288
• Other Study ID Numbers: B6310
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Colorado, Boulder
• Study Sponsor: University of Colorado, Boulder
• Collaborators: Not Provided

Investigators

• 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