○ Human lifespan benefit: not established by the compiled studies. Included records: no healthy-aging lifespan RCT — human evidence is randomized placebo-controlled RCTs with functional endpoints (muscle strength/endurance) and biomarker endpoints (mitochondrial gene signature, immune markers)

What it is

Class: Gut-microbiome metabolite; mitophagy activator

Also known as: Mitopure (a branded urolithin A ingredient), UA

Relationship to mitochondrial health: Urolithin A is a metabolite that some people's gut bacteria produce from dietary ellagitannins (pomegranate, walnuts, berries). It is studied as a mitophagy inducer — promoting the selective clearance of damaged mitochondria — with downstream effects reported on muscle mitochondrial biomarkers and function.

Regulatory status

Sold as a dietary ingredient (Mitopure) with a US FDA GRAS notification for food use; not an approved drug and not approved for any anti-aging, longevity, or healthspan indication. GRAS food status is a safety/food-use pathway, NOT evidence of an aging benefit.

Mechanism

Induces mitophagy (clearance of damaged mitochondria) and is reported to shift a mitochondrial gene-expression signature; human trials measure muscle strength/endurance and mitochondrial or immune biomarkers. See Mitophagy (PINK1 / Parkin).

Evidence — Human (randomized, placebo-controlled) verify: source publication identified; see evidence and limitations

Species / population	Study populations differ: sedentary older adults (Andreux 2019); overweight adults aged 40–64 (Singh 2022); adults aged 65–90 (Liu 2022); 50 generally healthy adults aged 45–70 in a 28-day immune-biomarker trial (Denk 2025).
Exposure, route, schedule	Oral urolithin A (commonly 500-1000 mg/day) for weeks to months.
Comparator / duration	Placebo-controlled, randomized in the pivotal trials.
Endpoint / numeric result	Singh 2022 did not meet the primary peak-power endpoint; secondary hamstring strength improved, while exercise/walking changes were not significant versus placebo. Liu 2022 did not meet the primary walking/ATP endpoints; secondary muscle endurance improved at 2 months but not versus placebo at 4 months. Andreux 2019 reported short-term tolerability/gene-expression findings; Denk 2025 reported 28-day immune biomarkers.
What it did NOT establish	No healthy-aging lifespan or hard clinical outcome. Functional/biomarker gains do not establish extended human lifespan or disease prevention.

Evidence — Animal / invertebrate verify: source publication identified; see evidence and limitations

Species / population	C. elegans and rodents (Ryu 2016).
Exposure, route, schedule	Dietary urolithin A.
Comparator / duration	Vehicle/untreated controls.
Endpoint / numeric result	Induced mitophagy, prolonged lifespan in C. elegans, and improved muscle function in rodents.
What it did NOT establish	Invertebrate lifespan and rodent muscle gains do not transfer to a human lifespan claim.

Negative or null findings

The primary peak-power endpoint in Singh 2022 was not significant; within-group exercise/walking improvements must not be described as significant placebo-controlled effects.
The primary walking and ATP endpoints in Liu 2022 were not significant; muscle-endurance differences versus placebo were significant at 2 months, not 4 months.
These included trials do not establish a healthy-human lifespan or disease-prevention benefit.

The form used in the trials

A product-fact block, not a recommendation. It records the form the trials used and what they administered. MitoiX does not rank products, name a best one, suggest a dose, or claim an effect.

Amount used in the trials	Oral urolithin A (commonly 500-1000 mg/day) for weeks to months.
Trial population	Study populations differ: sedentary older adults (Andreux 2019); overweight adults aged 40–64 (Singh 2022); adults aged 65–90 (Liu 2022); 50 generally healthy adults aged 45–70 in a 28-day immune-biomarker trial (Denk 2025).
Regulatory status	Sold as a dietary ingredient (Mitopure) with a US FDA GRAS notification for food use; not an approved drug and not approved for any anti-aging, longevity, or healthspan indication. GRAS food status is a safety/food-use pathway, NOT evidence of an aging benefit.

Brand studied	Mitopure
Compound	urolithin A (Amazentis material)
Dose studied	500-1000 mg/day in the human trials
Study record	singh-2022-muscle

Singh 2022 identifies oral Urolithin A (Mitopure; Amazentis SA) in its trial design and key-resources table. This is a brand-scoped retailer search, not confirmation of the identity, formulation or quality of every search result.

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Urolithin A