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....
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).
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.
Parallel
Urolithin A
Dietary supplementUrolithin 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
Dietary supplementThe placebo will consist of methylcellulose and will appear identical to the active supplement. The placebo will be provided by the manufacturer of Urolithin A.
To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation.
Study visits 1 - 5
To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation.
Study visits 1 - 5
To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation.
Study visits 1 \& 5
To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation.
Study visits 1 \& 5
To determine if UA supplementation will alter gut microbiome composition.
Study visits 1, 3 \& 5
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