180 Participants Needed

Urolithin A for Healthy Adults

DL
JM
Overseen ByJosephine M Egan, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Institute on Aging (NIA)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on glucose-lowering drugs, you cannot participate. Also, you should not be on any investigational drugs or require long-term treatment with antibiotics, corticosteroids, or immunosuppressors.

What evidence supports the effectiveness of the treatment Urolithin A for healthy adults?

Research shows that Urolithin A, a compound from foods like pomegranates and berries, can improve cell health and reduce inflammation, which may help with aging and related conditions. It has shown benefits in muscle health in older adults and may help prevent diseases like Alzheimer's and type 2 diabetes by reducing inflammation.12345

Is Urolithin A safe for humans?

Research on Urolithin A, a compound found in foods like pomegranates and nuts, shows it is not toxic in animal studies, with no harmful effects observed at high doses. It has been tested in rats without causing any health issues, suggesting it is generally safe.16789

How is the drug Urolithin A unique compared to other treatments?

Urolithin A is unique because it is a natural compound produced by gut bacteria from foods like pomegranates and berries, and it enhances cellular health by improving mitochondrial function and reducing inflammation. Unlike other treatments, not everyone can naturally produce Urolithin A due to gut microbiome differences, making direct supplementation a novel approach to ensure consistent benefits across individuals.1241011

What is the purpose of this trial?

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....

Research Team

JM

Josephine M Egan, M.D.

Principal Investigator

National Institute on Aging (NIA)

Eligibility Criteria

This trial is for healthy adults aged 55 or older with a body mass index (BMI) of 27 or higher. Participants will be involved in the study for about 8 weeks, which includes taking gelcaps daily and undergoing various tests such as blood draws after drinking a sweet liquid, wearing a glucose monitor, exercising on a treadmill, and having imaging scans.

Inclusion Criteria

Provision of signed and dated informed consent form
Able to speak and read English (We do not have ready access to interpreters of different languages at the NIA Clinical Unit)
In good general health, as evidenced by medical history/physical exam/laboratory results
See 5 more

Exclusion Criteria

Fasting glucose >= 126 on screening visit
Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment
On average, consumes more than 1 alcoholic drink per day
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Urolithin A or placebo for 8 weeks with various tests including oral glucose tolerance, continuous glucose monitoring, and exercise tests

8 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Urolithin A
Trial Overview The trial is testing whether Urolithin A (UA), taken as gelcaps every morning, can improve insulin levels and help control blood sugar compared to a placebo. Half of the participants will receive UA while the other half will get a placebo that looks identical but contains no medicine.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Urolithin AActive Control1 Intervention
50% of participants
Group II: PlaceboPlacebo Group1 Intervention
50% of participants

Urolithin A is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Urolithin A for:
  • Generally Recognized as Safe (GRAS) for dietary supplement use
🇪🇺
Approved in European Union as Urolithin A for:
  • No specific therapeutic indications approved; available as a dietary supplement

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute on Aging (NIA)

Lead Sponsor

Trials
1,841
Recruited
28,150,000+

Findings from Research

Urolithins, which are metabolites derived from ellagic acid, are better absorbed in the body and may be responsible for the health benefits associated with foods containing ellagitannins.
This study successfully developed a new method to synthesize specific urolithin glucuronides, which are important for understanding their mechanisms of action in human cells, and confirmed their presence in different human metabotypes.
Novel Regioselective Synthesis of Urolithin Glucuronides─Human Gut Microbiota Cometabolites of Ellagitannins and Ellagic Acid.Villalgordo, JM., Trulli, L., García-Villalba, R., et al.[2022]
Urolithin A (UA), derived from gut bacteria processing ellagitannins found in foods like pomegranate and berries, has been shown to enhance cellular health by promoting mitophagy and improving mitochondrial function while reducing inflammation.
Recent clinical trials indicate that UA supplementation can provide benefits for muscle health in elderly individuals, suggesting its potential as a nutritional intervention to combat aging and age-related conditions.
Impact of the Natural Compound Urolithin A on Health, Disease, and Aging.D'Amico, D., Andreux, PA., Valdés, P., et al.[2021]
Urolithin A (UroA), derived from foods like pomegranates and walnuts, shows promise as a therapeutic agent due to its ability to reduce inflammation in various tissues, which may help prevent diseases like Alzheimer's and type 2 diabetes.
Research indicates that UroA's anti-inflammatory effects could be harnessed through dietary sources or as a pharmaceutical treatment, highlighting its potential role in managing immunometabolic diseases.
Immunomodulatory Role of Urolithin A on Metabolic Diseases.Toney, AM., Fox, D., Chaidez, V., et al.[2021]

References

Novel Regioselective Synthesis of Urolithin Glucuronides─Human Gut Microbiota Cometabolites of Ellagitannins and Ellagic Acid. [2022]
Impact of the Natural Compound Urolithin A on Health, Disease, and Aging. [2021]
Immunomodulatory Role of Urolithin A on Metabolic Diseases. [2021]
The Synthesis of Urolithins and their Derivatives and the Modes of Antitumor Action. [2023]
Identification of Novel Urolithin Metabolites in Human Feces and Urine after the Intake of a Pomegranate Extract. [2019]
Safety assessment of Urolithin A, a metabolite produced by the human gut microbiota upon dietary intake of plant derived ellagitannins and ellagic acid. [2018]
A natural molecule, urolithin A, downregulates androgen receptor activation and suppresses growth of prostate cancer. [2020]
The gut microbiota metabolism of pomegranate or walnut ellagitannins yields two urolithin-metabotypes that correlate with cardiometabolic risk biomarkers: Comparison between normoweight, overweight-obesity and metabolic syndrome. [2019]
Induction of Autophagy and Activation of SIRT-1 Deacetylation Mechanisms Mediate Neuroprotection by the Pomegranate Metabolite Urolithin A in BV2 Microglia and Differentiated 3D Human Neural Progenitor Cells. [2019]
Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. [2022]
Urolithins, the rescue of "old" metabolites to understand a "new" concept: Metabotypes as a nexus among phenolic metabolism, microbiota dysbiosis, and host health status. [2018]
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