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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575288
Other study ID # B6310
Secondary ID
Status Completed
Phase N/A
First received April 6, 2012
Last updated December 9, 2015
Start date May 2012
Est. completion date December 2015

Study information

Verified date December 2015
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 79 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Colorado, Boulder Clinical Translational Research Center Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial Stiffness Arterial pulse wave velocity 12 weeks No
Primary 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 No
Secondary Systemic oxidative stress and inflammation circulating markers of oxidative stress and inflammation 12 weeks No
Secondary Endothelial cell oxidative stress and inflammation inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells 12 weeks No
Secondary Insulin sensitivity intravenous glucose tolerance test 12 weeks No
Secondary Endothelial cell autophagic flux 12 weeks No
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