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

Healthy Volunteer Clinical Trial

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

Status Recruiting

Clinical Trial 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....

Clinical Trial 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 mitochondrial function in brain and muscle tissues. (iv) alter gut microbiome. These effects will be examined over an 8-week period. The study will include a Screening Visit and 5 additional study visits.

Objectives:

Primary Objective:

To determine if UA supplementation will increase the rate at which beta cells respond to glucose.

Secondary Objectives:

Investigate if UA alters incretin secretion in response to oral glucose (incretins are secreted only in response to nutrients) and uncover if UA increases brain and skeletal muscle metabolism.

Endpoints:

Primary Endpoint:

To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation.

Secondary Endpoints:

• To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation.

• To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation.

• To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation.

• To determine if UA supplementation will alter gut microbiome composition.

• To determine if Uroltihin A supplementation alters the percentage of immune cell types. ;

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT06274749
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Denise L Melvin, R.N.
• Phone: (410) 350-3924
• Email: melvinde@mail.nih.gov
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2024
• Completion date: March 31, 2027