NCT06274749

Brief 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....

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 21, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 16, 2026

Status Verified

September 29, 2025

Enrollment Period

11 months

First QC Date

February 22, 2024

Last Update Submit

April 15, 2026

Conditions

Healthy Volunteer

Keywords

Urolithin AGLUCOSE METABOLISMInsulinMuscle StrengthMicrobiomes

Outcome Measures

Primary Outcomes (1)

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

    Study visits 1 - 5

    8 weeks

Secondary Outcomes (4)

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

    8 weeks

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

    8 weeks

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

    8 weeks

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

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

50% of participants

Dietary Supplement: Placebo

Urolithin A

ACTIVE COMPARATOR

50% of participants

Dietary Supplement: Urolithin A

Interventions

Urolithin ADIETARY_SUPPLEMENT

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.

Urolithin A
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Insulin Resistance

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Josephine M Egan, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise L Melvin, R.N.

CONTACT

(410) 350-3924melvinde@mail.nih.gov

Josephine M Egan, M.D.

CONTACT

(410) 558-8414eganj@mail.nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 23, 2024

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 16, 2026

Record last verified: 2025-09-29

Data Sharing

IPD Sharing
Will not share

Locations

US(1)