Actively Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Led by National Institute on Aging (NIA) · Updated on 2026-05-14
180
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with all study procedures and available for the entire study duration.
- Male or female, age 55 years or older.
- Able to speak and read English.
- Body mass index (BMI) 27 or higher.
- Able to take oral medication and willing to follow daily regimen.
- Able to perform walking and treadmill tests without physical limitations.
- In good general health as shown by medical history, physical exam, and lab results.
You will not qualify if you...
- History of diabetes treated with glucose-lowering drugs.
- Fasting glucose 126 mg/dL or higher at screening.
- Use of investigational drugs or interventions within 8 weeks before enrollment.
- Hospitalization within past 12 months for heart attack, coronary procedures, or stroke.
- History of autoimmune diseases like Hashimoto's thyroiditis, Myasthenia Gravis, or Rheumatoid Arthritis.
- Uncontrolled thyroid disease.
- Chronic liver disease or liver enzymes more than twice normal.
- Chronic kidney disease or estimated glomerular filtration rate less than 60 mL/min/1.73 m².
- Anemia (hemoglobin less than 12 g/dL for men or less than 11 g/dL for women).
- Poor venous access.
- Uncontrolled high blood pressure.
- Significant gastrointestinal diseases such as IBS or Crohn's disease.
- Active cancer or cancer treatment within the past year.
- Medical condition requiring long-term antibiotics, corticosteroids, or immunosuppressants.
- Currently pregnant or nursing.
- History or lab evidence of HIV, Hepatitis B, or Hepatitis C at screening.
- Positive urine drug test at screening (unless prescribed and approved by the investigator).
- Claustrophobia or ineligibility for MRI.
- Weight 300 lbs or more (MRI limit).
- Hip or knee replacement or other conditions preventing MRI scans.
- Diagnosed cognitive impairment preventing informed consent.
- Current smoker or tobacco use in past year.
- History of substance abuse including marijuana use in past year.
- Average consumption of more than 1 alcoholic drink per day.
- Any condition that may affect ability to complete the study or pose significant risk as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
D
Denise L Melvin, R.N.
CONTACT
J
Josephine M Egan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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