Urolithin A supplementation's effects on glucose metabolism in older adults

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

This study is testing if a natural supplement called Urolithin A can help older adults improve their blood sugar control and insulin response.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 55 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06274749 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of Urolithin A (UA), a natural nutritional supplement, on glucose metabolism in healthy adults aged 55 and older. Participants will be randomly assigned to receive either UA or a placebo over an 8-week period, with assessments of insulin secretion and other metabolic markers conducted at multiple clinic visits. The study aims to determine if UA can enhance insulin response and improve glucose control, potentially benefiting metabolic health in older adults.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 55 years and older with a body mass index of 27 or higher.

Not a fit: Patients with a history of diabetes requiring treatment with glucose-lowering drugs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glucose metabolism and reduced risk of diabetes in older adults.

How similar studies have performed: While the specific effects of Urolithin A on glucose metabolism are novel, similar studies on dietary supplements and metabolic health have shown promising results.

Eligibility criteria

* 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 without physical limitations.
* In good general health, as evidenced by medical history/physical exam/laboratory results.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* 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.

Where this trial is running

Baltimore, Maryland

• National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Josephine M Egan, M.D. — National Institute on Aging (NIA)
• Study coordinator: Denise L Melvin, R.N.

Conditions: Healthy Volunteer, Urolithin A, GLUCOSE METABOLISM, Insulin, Muscle Strength, Microbiomes