Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

55 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

180 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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....

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availably for the duration of the study.
• Male or female, age \>= 55 years.
• Able to speak and read English. (We do not have ready access to interpreters of different languages at the NIA Clinical Unit).
• BMI \>= 27.
• Ability to take oral medication and be willing to adhere to the daily regimen.
• Ability to perform walking and treadmill tests without physical limitations.
• In good general health, as evidenced by medical history/physical exam/laboratory results.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

• History of diabetes requiring treatment with any glucose lowering drug(s).
• Fasting glucose \>= 126 on screening visit.
• Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment.
• Hospitalization within 12 months for myocardial infarction, coronary revascularization or bypass surgery or stroke.
• History of autoimmune disease, e.g., Hashimoto s thyroiditis, Myasthenia Gravis or Rheumatoid Arthritis.
• Uncontrolled thyroid disease.
• Chronic liver disease indicated by medical history or one of the liver enzymes greater than 2 times the normal range.
• History of chronic kidney disease or GFR \<60 mL/min/1.73 m\^2.
• Anemia (defined as hemoglobin level \<12 g/dl for men or \< 11 g/dl for women).
• Poor venous access.
• Uncontrolled hypertension as judged by the Investigator.
• History of significant GI disease, e.g., IBS, Crohn s disease.
• Active cancer or has had treatment for cancer in the last 1 year.
• Medical condition requiring absolute and continuous need for long-term treatment with antibiotics, corticosteroids, immunosuppressors.
• Currently pregnant or a nursing mother due to possible changes in hormones and metabolism.
• History of, or laboratory evidence of HIV virus infection at Screening Visit.
• History of, or laboratory evidence of Hepatitis B or C at Screening Visit.
• Positive urine drug screen at Screening Visit (unless taking prescribed medication and at the discretion of the PI).
• Reports claustrophobia and/or is not eligible to have an MRI as per the MRI eligibility form.
• Weight \>= 300 lbs (MRI scanner weight limit).
• Hip or knee replacement or other medical condition that prevents MRI research scans from being performed.
• Diagnosed with cognitive impairment that clearly prevents the participant from providing informed consent.
• Current smoker or tobacco use in the past year.
• History of substance abuse, including marijuana use in the past year.
• On average, consumes more than 1 alcoholic drink per day.
• Any other condition which in the investigator s opinion may adversely affect the subject s ability to complete the study or its measures or which may pose significant risk to the subject.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute on Aging (NIA)

Study start

Nov 15, 2026 Estimated

Primary completion

Mar 31, 2027 Estimated

Study completion

Mar 31, 2027 Estimated

First posted

Feb 23, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts