The Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults >= 55 Years Old. A Randomized Triple-Masked Controlled Clinical Trial
National Institute on Aging (NIA)
Summary
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....
Description
Study Description: We hypothesize that supplementation with the nutritional supplement urolithin A (UA) in healthy adults \>= 55 years old will; (i) increase insulin secretion by boosting beta cell metabolism of glucose, resulting in increased ATP generation as pyruvate enters the TCA cycle after glycolysis, thereby enhancing early, acute insulin secretion and glucose uptake in skeletal muscle -both of which will lower circulating levels of blood glucose, (ii) boost production and secretion of incretin hormones because their secretion is also dependent on cellular depolarization, (iii) boost…
Eligibility
- Age range
- 55–100 years
- Sex
- All
- Healthy volunteers
- No
* 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 w…
Interventions
- Dietary SupplementUrolithin A
Urolithin 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.
- Dietary SupplementPlacebo
The placebo will consist of methylcellulose and will appear identical to the active supplement. The placebo will be provided by the manufacturer of Urolithin A.
Location
- National Institute of Aging, Clinical Research UnitBaltimore, Maryland