Our studies
At our core, we stand against pseudoscience. For over 15 years, we have pioneered meaningful scientific discoveries on Urolithin A and put them to the scrutiny of the scientific community by publishing in high impact, peer-reviewed journals. Our dedication to rigorous research sets us apart from dietary supplement and skin care companies that rely on hype and unsubstantiated claims.
Clinical studies
Studies in humans to assess safety, efficacy, and optimal dosages of new treatments or interventions, often conducted in multiple phases.
Title
Scientific journal
A double-blind, placebo-controlled study shows that Urolithin A (Mitopure) significantly improves muscle strength (∼12%). Researchers observe clinically meaningful improvements with Urolithin A on aerobic endurance (peak oxygen oxygen consumption [VO2]) and physical performance (6 min walk test) but do not notice a significant improvement on peak power output (primary endpoint). Plasma acylcarnitines and C-reactive proteins were significantly lower, indicating higher mitochondrial efficiency and reduced inflammation. Urolithin A also increased protein expression linked to mitophagy and mitochondrial metabolism in skeletal muscle.
This is a randomized, double-blind, placebo-controlled trial found that urolithin A (Mitopure) supplementation was safe and well tolerated in adults aged 65 to 90 years. Although the improvements in the 6-minute walk distance and maximal ATP production in the hand muscle were not significant in the urolithin A group vs the placebo group, long-term urolithin A supplementation (1,000 mg Mitopure) was beneficial for muscle endurance and plasma biomarkers, suggesting that urolithin A may counteract age-associated muscle decline.
We report the results of a first-in-human clinical trial in which we administered Urolithin A (Mitopure), either as a single dose or as multiple doses over a 4-week period, to healthy, sedentary elderly individuals. We show that Urolithin A (UA) has a favourable safety profile (primary outcome). UA was bioavailable in plasma at all doses tested, and 4 weeks of treatment with UA at doses of 500 mg and 1,000 mg modulated plasma acylcarnitines and skeletal muscle mitochondrial gene expression in elderly individuals (secondary outcomes). These observed effects on mitochondrial biomarkers show that UA induces a molecular signature of improved mitochondrial and cellular health following regular oral consumption in humans.
This study investigated the prevalence of Urolithin A (UA) producers in a healthy population and the effectiveness of direct UA supplementation with Mitopure to overcome microbiome and dietary variability. Only 12% of subjects had detectable levels of UA at baseline. Following pomegranate juice intake, ~40% of the subjects converted precursor compounds into UA. UA producers had higher gut microbiome diversity and were distinguished by a higher ratio of Firmicutes to Bacteroides. Direct UA supplementation significantly increased plasma levels and provided >6-fold exposure compared to pomegranate juice.
This clinical study evaluated mitochondrial (dys)function in pre-frail elderly (>60 years) compared to age-matched active elderly. Results showed impaired phosphocreatine recovery, lower mitochondrial respiratory complex protein and activity levels, and down-regulated mitochondrial genes in pre-frail individuals. Findings suggest that mitochondrial impairment is a key factor in pre-frailty development and muscle function decline in the elderly, highlighting potential targets for preventative interventions.
Study investigates how a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells (T-cells) in healthy adults and this results in better immune function.
This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.
The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)
The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.
The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.
The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method
Pre-clinical studies
Lab experiments conducted to evaluate safety, efficacy, and mechanisms of new treatments before human trials.
Title
Scientific journal
This study looked at the biological effects of UA in C. elegans (worms) and rodents to assess the health benefits. In C. elagans, UA prolonged lifespan and normal activity during aging. In rodents, UA improved exercise capacity in models of age-related muscle decline. These findings demonstrate the positive effects of UA and its potential role in strategies to improve mitochondrial function and muscle health.
This study showed that treatment with Amazentis’ proprietary Urolithin A supplement, Mitopure, significantly improved the cancer-fighting properties of T-cells, a key part of the immune system. Urolithin A renewed the energy factories of the T-cells via a cellular recycling pathway called mitophagy and so helped maintain their anti-cancer activity for longer, the research shows. These findings further highlight Urolithin A’s potential benefits for immune aging and cancer management.
OA affects 500M+ people worldwide with no effective therapy. Mitochondrial dysfunction contributes to OA pathology, but no interventions to rescue mitochondrial defects in human OA are available. Urolithin A (Mitopure) is a natural compound that promotes mitophagy and mitochondrial function. It improved mitophagy and mitochondrial respiration in primary chondrocytes from joints of healthy donors and OA patients. It also reduced disease progression in a mouse model of OA, decreasing cartilage degeneration, synovial inflammation, and pain, indicating UA's potential to improve mobility and alleviate OA pathology.
Mitochondrial dysfunction has been implicated in Duchenne muscular dystrophy (DMD). Luan and colleagues studied the role of mitophagy (mitochondrial autophagy) in muscle stem cells and DMD. Mitophagy was reduced in muscle biopsies from patients with muscular dystrophies and in mouse and worm models of DMD. Urolithin A, a mitophagy activator, up-regulated mitophagy-related genes and improved mitochondrial respiration, muscle stem cell regeneration and muscle function in models of DMD. This demonstrates how enhancing mitophagy could potentially help treat DMD.
Protocol: Ex-vivo human primary skin cells assay from healthy donorst reated with a dose of Mitopure® at 10uM or vehicle for 24 hours.
Protocol: Randomized and controlled to placebo treated split-face/arm study design where product was topically applied for 8 weeks.
15 years of research in healthy aging and longevity
Mitopure is the first and only clinically tested Urolithin A supplement. Our MDs and PhDs pioneered the first clinical studies with Urolithin A in humans.
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