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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorNational Institute on Aging (NIA)

About 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....

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Urolithin A
  • Placebo

Treatment groups

180 Participants
are divided into 2 treatment groups