Urolithin A for Healthy Adults
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on glucose-lowering drugs, you cannot participate. Also, you should not be on any investigational drugs or require long-term treatment with antibiotics, corticosteroids, or immunosuppressors.
What evidence supports the effectiveness of the treatment Urolithin A for healthy adults?
Research shows that Urolithin A, a compound from foods like pomegranates and berries, can improve cell health and reduce inflammation, which may help with aging and related conditions. It has shown benefits in muscle health in older adults and may help prevent diseases like Alzheimer's and type 2 diabetes by reducing inflammation.12345
Is Urolithin A safe for humans?
How is the drug Urolithin A unique compared to other treatments?
Urolithin A is unique because it is a natural compound produced by gut bacteria from foods like pomegranates and berries, and it enhances cellular health by improving mitochondrial function and reducing inflammation. Unlike other treatments, not everyone can naturally produce Urolithin A due to gut microbiome differences, making direct supplementation a novel approach to ensure consistent benefits across individuals.1241011
What is the purpose of this trial?
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....
Research Team
Josephine M Egan, M.D.
Principal Investigator
National Institute on Aging (NIA)
Eligibility Criteria
This trial is for healthy adults aged 55 or older with a body mass index (BMI) of 27 or higher. Participants will be involved in the study for about 8 weeks, which includes taking gelcaps daily and undergoing various tests such as blood draws after drinking a sweet liquid, wearing a glucose monitor, exercising on a treadmill, and having imaging scans.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Urolithin A or placebo for 8 weeks with various tests including oral glucose tolerance, continuous glucose monitoring, and exercise tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Urolithin A
Urolithin A is already approved in United States, European Union for the following indications:
- Generally Recognized as Safe (GRAS) for dietary supplement use
- No specific therapeutic indications approved; available as a dietary supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Aging (NIA)
Lead Sponsor