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

Launched by NATIONAL INSTITUTE ON AGING (NIA) · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a natural supplement called Urolithin A (UA) may help control blood sugar levels in healthy adults aged 55 and older. As we age, our bodies may not produce enough insulin, which can lead to higher blood sugar and potential health issues like diabetes. The goal of this study is to see if taking UA can improve insulin levels and other hormones that help manage blood sugar.

To participate, individuals must be at least 55 years old, have a body mass index (BMI) of 27 or higher, and be in generally good health. Participants will visit the clinic six times over eight weeks, where they will take either UA or a placebo—an inactive version of the supplement that looks the same. They will undergo various tests, including drinking a sugary liquid to check how their body processes glucose and wearing a continuous glucose monitor to track their blood sugar levels. This study will help researchers understand if UA can be a helpful tool for managing blood sugar in older adults.

Gender

ALL

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.