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

NCT ID: NCT01575288

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Vascular Aging

Keywords

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arterial function cardiovascular aging endothelial function arterial stiffness vascular function Trehalose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maltose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100g maltose 1/day

High-dose trehalose

Group Type EXPERIMENTAL

High-dose trehalose

Intervention Type DRUG

100g 1/day

Interventions

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Placebo

100g maltose 1/day

Intervention Type DRUG

High-dose trehalose

100g 1/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachelle E Kaplon, MS

Role: STUDY_DIRECTOR

University of Colorado, Denver

Douglas R Seals, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado, Boulder Clinical Translational Research Center

Boulder, Colorado, United States

Site Status

Countries

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United States

Related Links

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http://www.colorado.edu/intphys/research/cardiovascular.html

Description of our Research and Laboratory

Other Identifiers

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B6310

Identifier Type: -

Identifier Source: org_study_id