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Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Sponsor: National Institute on Aging (NIA)
Summary
Background: As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose. Objective: To learn if UA improves levels of insulin and other hormones that help control blood glucose. Eligibility: People aged 55 years and older with a body mass index of 27 or higher. Design: Participants will have 6 clinic visits over 8 weeks. Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. Participants will have tests during the study including: Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours. Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study. Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces. Imaging scans of the thigh; scans of the brain are optional....
Official title: The Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults >= 55 Years Old. A Randomized Triple-Masked Controlled Clinical Trial
Key Details
Gender
All
Age Range
55 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-04-14
Completion Date
2027-03-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Urolithin A
Urolithin A (UA) is a widely available dietary supplement devoid of any known sided effects that is reported to improve mitochondrial function. The UA substance used in this investigation is regulated under Generally Recognized as Safe (GRAS) by the US FDA (GRN No. 000791) (https://www.fda.gov/media/120300/download) and is being advertised and sold as an oral supplement. The daily dose (1 gram) and duration (8 weeks) have already been tested in previous clinical trials.
Placebo
The placebo will consist of methylcellulose and will appear identical to the active supplement. The placebo will be provided by the manufacturer of Urolithin A.
Locations (1)
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States