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FrailtyMitoEMNCT06556706

Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults

A study testing Mitopure (Urolithin A) in people with Frailty and Sarcopenia, run by Amazentis SA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Frailty, Sarcopenia, Aging
What is being tested?
Mitopure (Urolithin A)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteCanada
Study dates
15 Aug 2024to 25 Apr 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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female.
  • A body mass index between 18 to 35 kg/m2.
  • Not on any medications/living with medical conditions that would compromise the study outcome or the safety of the research participant.
  • Able to participate and willing to give written informed consent and to comply with the study restrictions.
  • Willing to be assigned randomly either to the UA or the control group.

Who cannot join

  • Participants must not have:
  • Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year.
  • A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
  • A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
  • A history or presence of allergy to lidocaine.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
Show all 18Show fewer
  • Unwillingness or inability to refrain from consuming alcohol within 48 hours before each visit until the end of said visit.
  • Unwillingness or inability to refrain from consuming 8 or more units of xanthine containing beverages and foods per day during the entire study.
  • Unwillingness to not consume other mitochondrial supplements during the course of the study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice
  • unwillingness to not change diet or physical activity levels during the course of the study
  • Unwillingness or inability to undergo a muscle biopsy.
  • Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements.
  • Unintentional weight loss ≤5% of regular body weight during the last 6 months.
  • Medication requirements that may interfere with the interpretation of the results.
  • Loss or donation of blood over 500mL three months prior (male subjects) or four months prior (female subjects) to participating in the study.
  • Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior to the start of the study;
  • Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study (Alcohol: more than 10 drinks a week, with more than 2 drinks a day most days; Drugs: THC, cocaine, opiates, amphetamines/methamphetamines, benzodiazepines, barbiturates, Buprenorphine, Creatin, Methadone metabolite, oxycodone, phencyclidine);
  • A positive COVID-19 test taken 1 week to 24h before study start date.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Center

    Montreal

Other trials in Canada

About this study

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation

Being tested
Mitopure (Urolithin A), Placebo
Keywords
mitophagy, Urolithin A
Medical subject headings
Frailty, Sarcopenia, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitopure (Urolithin A)Dietary supplement

    UA is produced by the gut microbiome following the digestion of dietary precursors (polyphenols such as ellagitannins and punicalagins) present in fruits and nuts such as pomegranate, nuts and berries.

    In mouse models of aging and muscle dystrophy, UA was shown to induce mitophagy and mitochondrial function in the skeletal muscle. This was associated with improved muscle strength and endurance (Nat. Med, 2016; Sci Tran Med, 2021). In humans, UA was shown to be safe and bioavailable in multiple clinical studies (Nat. Met, 2019; Cell Rep Med, 2022; JAMA Network Open, 2022).

  • PlaceboDietary supplement

    Placebo containing excipients other than Urolithin A (Mitopure)

Study groups in NCT06556706
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo
Mitopure (Urolithin A)Active comparatorNot described
Receives: Dietary Supplement: Mitopure (Urolithin A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy

    Measured: 8-weeks

  2. Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy

    Measured: 8-weeks

Secondary outcomes (16)

  1. change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers

    Measured: 8-weeks

  2. change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium

    Measured: 8-weeks

  3. mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR

    Measured: 8-weeks

  4. Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass

    Measured: 8-weeks

  5. Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue

    Measured: 8-weeks

  6. Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around and sit back down in the chair)

    Measured: 8-weeks

  7. Changes in grip strength measured by a hand dynamometer

    Measured: 8-weeks

  8. Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task

    Measured: 8-weeks

  9. Changes in distance walked during the six-minute walk test

    Measured: 8-weeks

  10. Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-seconds.

    Measured: 8-weeks

  11. Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor

    Measured: 8-weeks

  12. Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be asked to stand on one leg (barefoot) with eyes open and again with eyes closed

    Measured: 8-weeks

  13. Recording of adverse events

    Measured: 8-weeks

  14. Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling

    Measured: 8-weeks

  15. Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining)

    Measured: 8-weeks

  16. Changes in knee extension strength measured by a hand dynamometer

    Measured: 8-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start15 Aug 2024
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556706
Sponsor's protocol ID
2024-10182
Acronym
MitoEM
Status last verified
May 2025
First submitted
9 Aug 2024
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Girish Oswal D, Rane M. Is Urolithin A(UA) a pharmacologically credible neuro-nutraceutical? A critical review of mechanisms, brain exposure, and evidence gaps in Alzheimer's and Parkinson's disease. Neurochem Int. 2026 Oct;199:106224. doi: 10.1016/j.neuint.2026.106224. Epub 2026 Jul 17.

    PubMed 42468665

Questions about this trial

What is this clinical trial studying?

A study testing Mitopure (Urolithin A) in people with Frailty and Sarcopenia, run by Amazentis SA at 1 site in Canada.

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 5 inclusion and 18 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 28 May 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 Canada. 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 mitochondrial area between placebo and active treated groups assessed via Electron Microscopy (time frame: 8-weeks). The study lists 2 primary outcomes in all. 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 NCT06556706, 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 28 May 2025.

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