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

Start Date03 Feb 2026

Sponsor / Collaborator

National Institute on Aging

CTRI/2025/10/095887

/ Not yet recruitingNot ApplicableIIT

A double- blind randomised placebo-controlled trial of Urolithin-A for deficit symptoms in Schizophrenia: focus on dysfunctional mitophagy - MIND-UA

Start Date01 Feb 2026

Sponsor / Collaborator-

ISRCTN47159002

/ RecruitingNot Applicable

A confirmatory, randomised, double-blind, placebo-controlled, parallel study to assess the effects of a dietary supplement containing Urolithin A (Mitopure®) on muscle strength and performance in healthy middle-aged adults

Start Date15 Nov 2025

Sponsor / Collaborator

Amazentis SA

100 Clinical Results associated with Urolithin A

100 Translational Medicine associated with Urolithin A

100 Patents (Medical) associated with Urolithin A

553

Literatures (Medical) associated with Urolithin A

01 Mar 2026·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Urolithin A protects against calcium oxalate-induced crystal formation and kidney injury by regulating PCK1 to restore mitophagy function in kidney stone disease

Article

Author: Sun, Xiaoyi ; Ma, Chenxi ; Gao, Chunlin ; Zhang, Pei ; Wang, Meiqiu ; Xia, Zhengkun ; Peng, Yingchao ; Liu, Jiuyu ; Li, Shan

Kidney stone disease (KSD) is one of the most common urological disorders, and oxalate-induced tubular epithelial cell injury plays a crucial role in stone-related renal damage. However, the mechanisms linking oxalate exposure to mitochondrial dysfunction remain unclear. Urolithin A (UA), a gut microbiota-derived metabolite of ellagitannins, is recognized for its antioxidant and mitophagy-promoting properties. This study investigated the renoprotective effects and mechanisms of UA in calcium oxalate (CaOx) crystal-induced renal injury. In mice, UA markedly reduced renal CaOx deposition, improved renal function, and alleviated kidney injury. Consistently, both in vivo and in vitro experiments demonstrated that UA restored oxalate-suppressed mitophagy while also alleviating oxidative stress, apoptosis, and mitochondrial dysfunction. Transcriptomic and molecular docking analyses identified phosphoenolpyruvate carboxykinase 1 (PCK1) as a downstream target of UA. UA restored PCK1 expression under oxalate stress both in vivo and in vitro, whereas pharmacological inhibition of PCK1 weakened the renal protective and mitophagy-promoting effects. Conversely, PCK1 overexpression enhanced mitophagy under high-oxalate conditions. These findings indicate that UA alleviates CaOx-induced renal injury by activating PCK1-dependent mitophagy and restoring mitochondrial homeostasis. Given its natural origin and favorable safety profile, UA represents a promising candidate for preventing or treating calcium oxalate-associated renal injury.

01 Feb 2026·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Naringenin-functionalized polyester nanoparticles improve oral urolithin A delivery and protect against cisplatin-induced kidney injury via heme oxygenase-1 activation and mitochondrial quality control

Article

Author: Bolisetty, Subhashini ; Arora, Meenakshi ; Wahab, Abiodun T ; Kumar, M N V Ravi ; Ganugula, Raghu ; Sheikh-Hamad, David

Cisplatin remains a cornerstone of chemotherapy, but its clinical use is often limited by cisplatin-induced acute kidney injury, a condition driven by oxidative stress, inflammation, and mitochondrial dysfunction. Here, we developed naringenin-functionalized polyester nanoparticles (P2Ns-NAR) to enhance the oral delivery and therapeutic efficacy of urolithin A (UA), a mitochondrial-targeting metabolite with cytoprotective properties. The resulting formulation, P2Ns-NAR-UA, conferred kidney protection in vitro and in vivo, outperforming the nontargeted nanoparticle formulation (P2Ns-UA). Notably, in vivo efficacy was achieved at a 50% lower dose. Molecular docking studies suggest UA exhibits a favorable heme oxygenase-1 binding energy of -7.43 kcal/mol, supporting its potential as a promising drug candidate. Mechanistic studies demonstrated that P2Ns-NAR-UA upregulate heme oxygenase-1 and activate PTEN-induced putative kinase 1/Parkin-mediated mitophagy, promoting mitochondrial quality control and preserving dynamics by increasing mitofusin-1/2 and reducing dynamin-related protein 1 and mitochondrial fission protein 1 expression. Treatment also attenuated inflammatory cytokines (interleukin 6, interleukin 8, and tumor necrosis factor-α), immune activation markers (cluster of differentiation 80 and 45), and kidney injury biomarkers (neutrophil gelatinase-associated lipocalin, cystatin C, and osteopontin). Histological analysis confirmed reduced tubular damage and fibrosis. These findings establish P2Ns-NAR-UA as a promising oral therapeutic platform to mitigate cisplatin-induced acute kidney injury through coordinated modulation of inflammation, oxidative stress, and mitochondrial homeostasis. Further investigation in cisplatin-resistant cancer models is warranted to establish this platform's dual therapeutic potential and translational value. SIGNIFICANCE STATEMENT: This study shows that naringenin-functionalized polyester nanoparticles improves intestinal uptake of encapsulated agents through intestinal folate receptors. Naringenin-functionalized polyester nanoparticles loaded with urolithin A (P2Ns-NAR-UA) doubles the efficacy of polyester nanoparticles loaded with urolithin A, achieving comparable results at half the dose. The formulation enhances cell health, reduces inflammation, and restores kidney function, making it a promising adjuvant to cisplatin therapy by improving outcomes while minimizing toxicity.

01 Jan 2026·PHYTOTHERAPY RESEARCH

Pharmacological Regulation of Mitophagy by Natural Plant Products as a Therapeutic Target for Alzheimer's Disease

Review

Author: Shao, Simai ; Zu, Runru ; Peng, Quekun ; Lu, Hao ; Ma, Huifen ; Chen, Yuanzhao ; Sun, Yiran ; Peng, Zhichuan

ABSTRACT:

Alzheimer's disease (AD), a prevalent senile dementia, is characterized by the progressive decline in cognitive function, accumulation of tau tangles and Aβ plaques. Despite significant research efforts in the field of AD, effective therapeutic drugs for its prevention and treatment remain elusive. Consequently, a more comprehensive understanding of the molecular mechanisms underlying the pathological processes of AD is crucial for novel therapeutic strategies. Mitophagy, the selective degradation of mitochondria through autophagy, is an essential mechanism for maintaining mitochondrial homeostasis in terms of both quantity and quality. Mitophagy plays a crucial role in numerous cellular processes, including inflammation, differentiation, and apoptosis. Recent studies have increasingly demonstrated that mitophagy is extensively characterized in AD and may represent a novel therapeutic strategy for its treatment. Notably, a number of natural plant products (NPPs) have been demonstrated to modulate mitophagy and intervene in the pathological process of AD. For instance, NPPs such as urolithin A and β‐asarone have been reported to enhance mitophagy by activating the PINK1/Parkin pathway, thereby alleviating Aβ‐induced neurotoxicity. The distinctive multi‐target properties and favorable safety profiles of NPPs endow them with significant research potential and developmental value, establishing them as a vital resource for novel drug discovery. This review explores the mechanistic hypotheses linking mitophagy to AD pathology and provides a systematic overview of recent advances in representative NPPs that regulate mitophagy to alleviate AD‐related impairments, offering new perspectives for the development of therapeutic strategies against AD.

News (Medical) associated with Urolithin A

03 Nov 2025

·www.businesswire.com

Timeline Continues to Build the Most Clinically Researched Longevity Products Targeting Immune, Brain and Muscle Aging

LAUSANNE, Switzerland--(BUSINESS WIRE)--Timeline (Amazentis SA), the Swiss longevity biotech company behind Mitopure® (Urolithin A), today announced major scientific milestones reinforcing its position as a leader in clinically researched longevity supplements, targeting the three critical unmet needs of healthy aging: muscle, immune, and brain function. Expanding on its foundational clinical science on muscle health, Timeline announces the publication of a new clinical study on immune aging and the launch of a new clinical study for brain health. Immune: New first-in-class clinical results from the MitoImmune study, now published in the prestigious journal Nature Aging , validating for the first time that the mitochondrial enhancer, Mitopure® (Urolithin A), rejuvenated the immune system in humans. The 4-week study showed improvements in immune cell function and a reduction of inflammatory markers during the aging process, by improving mitochondrial health. https://www-nature-com.sutd.idm.oclc.org/articles/s43587-025-00996-x Brain: Timeline also announces its first-ever brain health clinical trial “CLARITY”. This marks Timeline’s 25th clinical trial and the largest ever brain aging study on a finished supplement product. Study: https://clinicaltrials.gov/study/NCT07060898 “Timeline is building the most clinically researched longevity consumer company in the world,” said Chris Rinsch, PhD, Co-Founder and President of Timeline. “We’re pushing the boundaries of healthspan science to enable people to stay stronger, sharper, and more resilient as they age.” Over the past 18 years, Timeline has invested more than $50 million in research and clinical development, resulting in 25 registered human trials and over 80 global patents centered around its proprietary ingredient Mitopure® (Urolithin A); a postbiotic that stimulates mitophagy, the body’s cellular recycling process critical for mitochondrial and metabolic health. Earlier this year, Timeline’s cutting-edge research was recognized as a top 40 winner in the Healthspan award by the XPRIZE. The MitoImmune study, a placebo-controlled clinical trial in 50 middle-aged adults, found that daily supplementation with Mitopure® improved the function and composition of key immune cells while reducing inflammatory markers following a 4-week supplementation period. The results, now peer-reviewed and published in Nature Aging, mark the first time a mitochondrial support supplement has shown such comprehensive clinically meaningful effects on immune aging in humans. “As we age, our immune system naturally becomes less effective. What’s remarkable here is that Urolithin A shows the potential to rejuvenate immune function by improving mitochondrial health, a completely new approach with real implications for healthy aging and quality of life.” said Professor Florian Greten, MD, principal investigator and Director of the Institute for Tumor Biology and Experimental Therapy, Georg-Speyer-Haus “It’s rare to see a supplement show measurable effects on immune aging in such a short time. By targeting the foundational cellular changes in immune cells instead of a temporary seasonal boost with Vitamin C for example , Urolithin A offers a unique way to help rejuvenate immune function, something that no other supplement has demonstrated at this level.” said collaborator Dr. Eric Verdin, MD, President and CEO of the Buck Institute of Aging To further investigate its potential on immune aging, Mitopure is now being evaluated in a follow-up clinical trial led by oncologist, Dr. Fabian Acker, MD at Goethe University, testing its role as a nutritional supplement to compliment immunotherapy in cancer patients. https://clinicaltrials.gov/study/NCT07161310 ### About Timeline® Timeline (parent company Amazentis) is a pioneering Swiss health science company committed to revolutionizing the longevity industry with its groundbreaking, clinically proven, proprietary ingredient Mitopure®. Offering a comprehensive approach to cellular health, Timeline incorporates the benefits of Mitopure inside its next-generation nutritional supplements and topical skin health products. With more than a decade of expertise in aging science research, Timeline seeks to push the boundaries of human healthspan, contributing to a future where everyone can live longer, healthier lives. The company is backed by over 15 years of research by distinguished scientists, multiple clinical studies, and over 50 global patents. Nestlé Health Science and L’Oréal are investors in the company. www.timeline.com About MitoImmune Title: Nature Aging “Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial” DOI: 10.1038/s43587-025-00996-x

Clinical StudyImmunotherapyClinical Result

05 May 2025

·www.prnewswire.com

Seed Health Presents New Clinical Trial Data: DS-01® Increases Two Key Microbiome Molecules Linked to Gut, Metabolic, Immune, and Cellular Health

DS-01® is the first broad-spectrum synbiotic clinically shown to increase production of both Urolithin A and butyrate—two key microbial metabolites linked to whole-body health Presented at Digestive Disease Week® (DDW) 2025, the findings expand DS-01®'s clinical foundation and reinforce the potential of microbiome-targeted products to impact multiple biological systems BOSTON, May 5, 2025 /PRNewswire/ -- Microbiome science company Seed Health presented clinical data on its flagship innovation, DS-01® Daily Synbiotic, at Digestive Disease Week® (DDW) 2025. Findings from a randomized, placebo-controlled clinical trial in healthy adults demonstrated that DS-01® increased production of two key microbial metabolites—Urolithin A and butyrate—implicated in gut barrier function, metabolism, and healthy aging. The trial also found reductions in C-Reactive Protein (CRP), a widely used marker of systemic inflammation, suggesting DS-01®'s potential to influence immune pathways. The findings underscore DS-01®'s impact beyond microbial composition, demonstrating measurable biological function through the production of microbiome-mediated metabolites. The company presented two posters during the "Prebiotics, Probiotics and Synbiotics in Health and Disease" session. Presentation Highlights Effects of a novel, broad-spectrum synbiotic on Urolithin A production: A randomized, placebo-controlled clinical trial This randomized, placebo-controlled clinical trial evaluated DS-01® for its ability to increase production of Urolithin A—a microbiome-derived metabolite linked to mitochondrial function, cellular energy, metabolic health, intestinal barrier integrity, and healthy aging. DS-01® provides the natural machinery to produce Urolithin A, delivering both a polyphenol precursor in its prebiotic outer capsule and key microbes in its probiotic inner capsule. Overall, this is the first study to demonstrate that a broad-spectrum synbiotic can increase Urolithin A production in humans. Key findings include: Rapid and Sustained Urolithin A Increase: DS-01® increased urinary Urolithin A levels by approximately 100-fold by Day 7 (P<0.0001), with levels sustained through Day 91. 100% Conversion to Urolithin A Producers: By Day 91, 100% of participants in the DS-01® arm became Urolithin A producers, compared to 44% in the placebo arm (P<0.01). Increased Lactobacillus spp. Abundance: DS-01® significantly increased the abundance of specific Lactobacillus species known to convert dietary polyphenols into Urolithin A precursors through Day 91 (P<0.001). A novel, broad-spectrum synbiotic increases butyrate production and decreases CRP: A randomized, placebo-controlled clinical trial This randomized, placebo-controlled trial evaluated DS-01® for its impact on butyrate and CRP. Butyrate is a key short-chain fatty acid (SCFA) produced by the gut microbiome, which fuels the cells that line the colon and supports immune function, gut barrier integrity, and metabolic signaling. CRP is a systemic marker of inflammation. The study is among the first to show that a broad-spectrum synbiotic can significantly increase butyrate levels in humans. Key findings include: Increased Butyrate Production: The synbiotic significantly increased fecal butyrate levels through Day 91 (P<0.03) in participants with low baseline butyrate levels; no change was observed in the placebo arm. Reduction in a Key Systemic Inflammatory Marker: There was a reduction in CRP, a marker of systemic inflammation, associated with the colonization of DS-01® species through Day 91 (P<0.02). Enhanced Microbiome Diversity: Participants in the synbiotic arm showed significantly higher diversity of Bifidobacterium and Lactobacillus species at all time points compared to placebo through Day 91 (P<0.0001). "This represents the first time a broad-spectrum synbiotic has been clinically shown to increase both Urolithin A and butyrate in humans," said Zain Kassam, M.D., M.P.H., Chief Medical Officer at Seed Health. "DS-01® is delivering measurable biological impact via the microbiome—driving the production of key metabolites long studied for their roles in gut barrier integrity, inflammation, and healthy aging. These findings expand the biological relevance of DS-01® and point to new applications of microbiome-targeted innovations in advancing systemic health." About Seed Health Seed Health is a microbiome science company pioneering innovations in probiotics and living medicines to impact human and planetary health. Founded to realize the potential of the microbiome, our platform enables the translation of breakthrough science across a portfolio targeting health outcomes from infancy to aging. Our consumer innovations are commercialized under Seed® —an award-winning, science-first brand known for clinically validated innovations in probiotics. Our pipeline encompasses both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin, pediatrics, mental health, metabolic function, and nutrition. Our environmental research is conducted under SeedLabs, which was founded to advance novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity. Press Contact [email protected] SOURCE Seed Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultMicrobial therapy

09 Jan 2025

·www.businesswire.com

Bonerge Announces the New 108 Person Clinical Trial: Exploring Skin and Organ Anti-Aging Innovations

NEW YORK--( BUSINESS WIRE )--Bonerge announced the initiation of its clinical trial, focusing on Fisetin, Urolithin A, and Ergothioneine. Involving 108 participants, this trial aims to evaluate their combined effects on skin health and organ rejuvenation when taking orally, providing more reliable options for the market. Senolytics Research: Advancing the Science of Anti-Aging In recent years, Senolytics research has advanced rapidly, with institutions like the Mayo Clinic and Wake Forest University at the forefront. Despite fruitful research, identifying optimal applications to translate Senolytics into market solutions remains crucial. In October 2024, the Mayo Clinic published groundbreaking findings in Nature Aging, identifying 67 plasma proteins, with IL-23R emerging as a promising anti-aging biomarker 1 . The study explored various promising Senolytics, including Fisetin, demonstrating a positive response in reducing senescence-related proteins and indicating potential for organ rejuvenation via senescent cell clearance 2 . The concept of organ rejuvenation offering deeper insights into its systemic effects and guiding anti-aging strategies. Senolytics show strong potential for organ rejuvenation applications and promise broader future prospects. Bonerge’s Clinical Trial: Exploring Skin as the Key to Rejuvenation The skin, the largest organ of the human body, is the most visible indicator of aging and a key target for anti-aging. Bonerge has launched a clinical trial focused on skin anti-aging, involving 108 participants. The trial evaluates skin anti-aging effects by assessing factors like skin heme, skin inflammation, transepidermal water loss, wrinkles, skin elasticity, skin firmness, melanin levels, and skin tone. Spanning 56 days, it aligns with two skin regeneration cycles, providing a detailed analysis of these key skin health indicators. Three ingredients tested in the trail: Fisetin: Among natural ingredients, fisetin has the strongest activity in clearing senescent cells. Its core mechanism promotes apoptosis of senescent cells and reduces SASP (Senescence-Associated Secretory Phenotype) secretion, alleviating chronic inflammation and combating inflammaging 3 , contributing to organ rejuvenation. Urolithin A: A rising star in nutritional supplements, Urolithin A has shown significant anti-photoaging effects. Photoaging, primarily caused by UVA (ultraviolet A) radiation, accelerates skin aging. Urolithin A helps protect skin by reducing the senescent phenotype of skin fibroblasts triggered by UVA, lowering intracellular ROS (reactive oxygen species), and activating antioxidant enzymes. These actions collectively support skin health and combat the harmful effects of photoaging 4 . Ergothioneine : Currently recognized as the only antioxidant that targets mitochondria, it reduces oxidative damage within mitochondria, supporting energy production and potentially preventing cellular aging 5 . Key Focus: Exploring Individual Ingredients and Combined Synergies In this clinical trial, while examining the skin anti-aging effects of individual ingredients, the combination of the three ingredients have also been tested to explore the synergistic effects on skin health and anti-aging. Path Ahead: Trial Progress and Future Expectations The clinical trial is progressing as planned and is expected to conclude in March 2025. Bonerge is hopeful that this study will provide valuable evidence for the anti-aging market, paving the way for the application of Senolytics in skin health and broader anti-aging treatments. References [1] Chase M. Carver, et al. IL-23R is a senescence-linked circulating and tissue biomarker of aging. Nature Aging, Dec 2024. [2] Researchers discover an aging and inflammation biomarker - Mayo Clinic News Network [3] Matthew J. et al. Fisetin is a senotherapeutic that extends health and lifespan. EBioMedicine 36 (2018). [4] Wenjie Liu , et al. Urolithin A protects human dermal fibroblasts from UVA-induced photoaging through NRF2 activation and mitophagy. J Photochem Photobiol B. 2022 Jul. [5] Brown, Lisa, et al. L-Ergothioneine and Its Protective Role in Cellular Health. Journal of Clinical Nutrition, vol 56.

Clinical Study

100 Deals associated with Urolithin A

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Indication	Highest Phase	Country/Location	Organization	Date
Cerebral Hemorrhage	Preclinical	China	Second Affiliated Hospital of Zhengzhou University	01 Nov 2025
Alzheimer Disease	Preclinical	United States	Texas Tech University Health Sciences Center	01 Jul 2025
Rheumatoid Arthritis	Preclinical	China	Zhejiang University	01 May 2025
Skin aging	Preclinical	China	Fudan University	07 Jul 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03283462 (Pubmed \| JAMA Netw Open)	Not Applicable	-	66	Urolithin A	gmwecvbfst(jdydkxtviu) = zjpmgmijnk vvvhrlpdrv (cowibfcnss )	-	04 Jan 2022
				Placebo	gmwecvbfst(jdydkxtviu) = sztdxglivz vvvhrlpdrv (cowibfcnss )

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