NCT01575288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

3.6 years

First QC Date

April 6, 2012

Last Update Submit

December 9, 2015

Conditions

Vascular Aging

Keywords

arterial functioncardiovascularagingendothelial functionarterial stiffnessvascular functionTrehalose

Outcome Measures

Primary Outcomes (2)

  • Arterial Stiffness

    Arterial pulse wave velocity

    12 weeks

  • nitric-oxide mediated endothelium-dependent dilation

    flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine

    12 weeks

Secondary Outcomes (4)

  • Systemic oxidative stress and inflammation

    12 weeks

  • Endothelial cell oxidative stress and inflammation

    12 weeks

  • Insulin sensitivity

    12 weeks

  • Endothelial cell autophagic flux

    12 weeks

Study Arms (2)

Maltose

PLACEBO COMPARATOR
Drug: Placebo

High-dose trehalose

EXPERIMENTAL
Drug: High-dose trehalose

Interventions

PlaceboDRUG

100g maltose 1/day

Maltose
High-dose trehaloseDRUG

100g 1/day

High-dose trehalose

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Boulder Clinical Translational Research Center

Boulder, Colorado, 80309, United States

Location

Related Links

MeSH Terms

Interventions

Trehalose

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesDisaccharidesOligosaccharidesSugars

Study Officials

  • Rachelle E Kaplon, MS

    University of Colorado, Denver

    STUDY DIRECTOR

  • Douglas R Seals, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2012

First Posted

April 11, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

US(1)