ObesityNCT05921266
Urolithin A Supplementation in Middle-aged Adults With Obesity
A study testing Urolithin A in people with Obesity and Vascular Dementia, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the effect of urolithin A, a dietary supplement, on blood flow in middle-aged adults with obesity. The main question it aims to answer is: Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?… Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Obesity, Vascular Dementia, Cognitive Impairment
- What is being tested?
- Urolithin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 14 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 40-64 years old, inclusive
- Obesity [BMI ≥30 kg/m2]
- Ability to read, write, and speak English
- Competence to provide written informed consent
Who cannot join
- Pregnant or breastfeeding women, or women who intend to become pregnant within the study period
- History of uncontrolled hypertension
- History of uncontrolled type 1 or type 2 diabetes mellitus
- Significant cardiac disease or chest pain in the last 6 months
- History of untreated depression or anxiety
- History of cognitive impairment
Show all 12Show fewer
- History of uncontrolled significant GI disease (e.g., IBS, Crohn's disease)
- Allergy or intolerance to one or more of the intervention components
- Undergoing treatment for active cancer
- History of neurodegenerative disorders (e.g., multiple sclerosis)
- Presence of any condition affecting swallowing ability
- Any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational GeroScience Laboratory - O'Donoghue Research Building
Oklahoma City, Oklahoma, 73117
About this study
Official title: Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
The goal of this clinical trial is to learn about the effect of urolithin A, a dietary supplement, on blood flow in middle-aged adults with obesity. The main question it aims to answer is:
- Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?
Participants will be asked to:
- Take the dietary supplement daily for 4 weeks
- Attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood
Researchers will compare people who took the dietary supplement with others who took a placebo to see if the blood flow in the blood vessels improved.
Read the detailed description
This study aims to measure the effect of urolithin A supplementation on endothelial function, cerebral blood flow regulation, and serum biomarkers of NO bioavailability and mitochondrial function in middle-aged adults with obesity. Briefly, 54 adults aged 40-64 years of age with a body mass index equal to or greater than 30 kg/m2 will be recruited to participate in a double-blind placebo-controlled parallel study for 4 weeks. Participants will be randomly assigned to intervention or control group. Those in the intervention group will consume 1,000 mg of urolithin A daily in the form of softgel capsules, whereas those in the control group will consume a placebo. Data collection will occur at baseline (day 0) and endpoint (day 28). The investigators will compare outcomes between control and intervention group. Researchers expect that urolithin A supplementation in middle-aged adults with obesity improves endothelial function and cerebral blood flow regulation, and that this improvement is accompanied by changes in biomarkers of NO bioavailability and mitochondrial function.
- Conditions
- Obesity, Vascular Dementia, Cognitive Impairment
- Being tested
- Urolithin A, Placebo
- Keywords
- Obesity, Urolithin A, Middle aged, Flow-mediated dilation, Endothelial function, fNIRS, Nitric oxide, Vascular contributions to cognitive impairment and dementia
- Medical subject headings
- Obesity, Dementia, Vascular, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urolithin ADietary supplement
Participants in the intervention group will receive 500 mg of urolithin A twice daily for 4 weeks (1,000 mg daily in total). The supplement will be administered in the form of softgels (4 softgels daily).
PlaceboOther
Participants in the control group will receive 0 mg of urolithin A twice daily for 4 weeks. The placebo will be administered in the form of inactive capsules (4 capsules daily).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Dietary Supplement: Urolithin A |
| Control | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial function and local stiffness
Flow-mediated dilation
Measured: Baseline (day 0) and endpoint (day 28)
Secondary outcomes (7)
Change in blood flow on the surface of the hand
Laser speckle contrast imaging
Measured: Baseline (day 0) and endpoint (day 28)
Change in reactive hyperemia index
EndoPAT
Measured: Baseline (day 0) and endpoint (day 28)
Change in homeostatic cerebral blood flow
Functional near-infrared spectroscopy
Measured: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Asymmetrical dimethylarginine
Measured: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Endothelin-1
Measured: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Bioactive nitrogen oxides
Measured: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of mitochondrial function
Acylcarnitines
Measured: Baseline (day 0) and endpoint (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start2 Oct 2023
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andriy Yabluchanskiy, MD, PhD, Principal investigator, University of Oklahoma Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921266
- Sponsor's protocol ID
- UA15561
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
da Costa Pinaffi-Langley AC, Gulej R, Kaposzta Z, Szarvas Z, Shahriari A, Kinnard H Jr, Ticer B, Pinto CB, Mukli P, Muranyi M, Adams C, Kong J, Anderson L, Tarantini S, Zhao YD, Hord NG, Yabluchanskiy A. Urolithin A and Endothelial and Cerebrovascular Function in Middle-Aged Adults With Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638047. doi: 10.1001/jamanetworkopen.2026.38047.
PubMed 42853569
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
- ClinicalTrials.gov ID
- NCT05921266
- Acronym / sponsor ID
- UA15561
- Conditions
- Obesity, Vascular Dementia, Cognitive Impairment
- Keywords
- Obesity, Urolithin A, Middle aged, Flow-mediated dilation, Endothelial function, fNIRS, Nitric oxide, Vascular contributions to cognitive impairment and dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the effect of urolithin A, a dietary supplement, on blood flow in middle-aged adults with obesity. The main question it aims to answer is:
- Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?
Participants will be asked to:
- Take the dietary supplement daily for 4 weeks
- Attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood
Researchers will compare people who took the dietary supplement with others who took a placebo to see if the blood flow in the blood vessels improved.
Detailed description
This study aims to measure the effect of urolithin A supplementation on endothelial function, cerebral blood flow regulation, and serum biomarkers of NO bioavailability and mitochondrial function in middle-aged adults with obesity. Briefly, 54 adults aged 40-64 years of age with a body mass index equal to or greater than 30 kg/m2 will be recruited to participate in a double-blind placebo-controlled parallel study for 4 weeks. Participants will be randomly assigned to intervention or control group. Those in the intervention group will consume 1,000 mg of urolithin A daily in the form of softgel capsules, whereas those in the control group will consume a placebo. Data collection will occur at baseline (day 0) and endpoint (day 28). The investigators will compare outcomes between control and intervention group. Researchers expect that urolithin A supplementation in middle-aged adults with obesity improves endothelial function and cerebral blood flow regulation, and that this improvement is accompanied by changes in biomarkers of NO bioavailability and mitochondrial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Urolithin A |
| Control | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 40-64 years old, inclusive
- Obesity [BMI ≥30 kg/m2]
- Ability to read, write, and speak English
- Competence to provide written informed consent
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women, or women who intend to become pregnant within the study period
- History of uncontrolled hypertension
- History of uncontrolled type 1 or type 2 diabetes mellitus
- Significant cardiac disease or chest pain in the last 6 months
- History of untreated depression or anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urolithin AParticipants in the intervention group will receive 500 mg of urolithin A twice daily for 4 weeks (1,000 mg daily in total). The supplement will be administered in the form of softgels (4 softgels daily). | Dietary supplement | Intervention |
| PlaceboParticipants in the control group will receive 0 mg of urolithin A twice daily for 4 weeks. The placebo will be administered in the form of inactive capsules (4 capsules daily). | Other | Control |
Primary outcome
Change in arterial function and local stiffness
Time frame: Baseline (day 0) and endpoint (day 28)
Flow-mediated dilation
7 secondary outcomes
Change in blood flow on the surface of the hand
Time frame: Baseline (day 0) and endpoint (day 28)
Change in reactive hyperemia index
Time frame: Baseline (day 0) and endpoint (day 28)
Change in homeostatic cerebral blood flow
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of mitochondrial function
Time frame: Baseline (day 0) and endpoint (day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 42853569da Costa Pinaffi-Langley AC, Gulej R, Kaposzta Z, Szarvas Z, Shahriari A, Kinnard H Jr, Ticer B, Pinto CB, Mukli P, Muranyi M, Adams C, Kong J, Anderson L, Tarantini S, Zhao YD, Hord NG, Yabluchanskiy A. Urolithin A and Endothelial and Cerebrovascular Function in Middle-Aged Adults With Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638047. doi: 10.1001/jamanetworkopen.2026.38047.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andriy Yabluchanskiy, MD, PhD principal investigator
University of Oklahoma Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urolithin A in people with Obesity and Vascular Dementia, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial function and local stiffness (time frame: Baseline (day 0) and endpoint (day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.