RECRUITING

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

Conditions

Healthy Volunteer Urolithin A GLUCOSE METABOLISM Insulin Muscle Strength Microbiomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

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

Quick Facts

Study Start:2025-03-09

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06274749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Denise L Melvin, R.N.

CONTACT

(410) 350-3924

melvinde@mail.nih.gov

Josephine M Egan, M.D.

CONTACT

(410) 558-8414

eganj@mail.nih.gov

Principal Investigator

Josephine M Egan, M.D.

PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Study Locations (Sites)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: National Institute on Aging (NIA)

Josephine M Egan, M.D., PRINCIPAL_INVESTIGATOR, National Institute on Aging (NIA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-09

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-03-09

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

Urolithin A
GLUCOSE METABOLISM
Insulin
Muscle Strength
Microbiomes

Additional Relevant MeSH Terms

Healthy Volunteer