HealthyENDURONCT04783207
Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
A study testing Mitopure in people with Healthy, run by Amazentis SA at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mitopure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Apr 2021to 30 Aug 2023
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-40 years
- Participants will be running >100 km/week
- Elite participants will be required to have a 3,000 m running personal best time below 9:00 (mm:ss), and/or a VO2max result greater than 65 ml·kg-1·min-1
- The sub-elite cohort will have a 3,000 m running personal best faster than 10:00 min and/or a VO2max >60 ml·kg-1·min-1
- Agree to participate in one of two ~4 week training camps been held between March-October 2021.
- Signed informed consent
Who cannot join
- Subjects with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
- Subjects who are unable to complete the training or testing protocols
Trial locations and contacts
1 site in 1 country.
Australia1 site
Australian Catholic University/Australian Institute of Sports
Canberra
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance in Athletes
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.
- Conditions
- Healthy
- Being tested
- Mitopure, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitopureDietary supplement
Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily
PlaceboDietary supplement
Softgel containing only excipients. 4 soft-gels to be taken daily
| Study group | Role | What they receive |
|---|---|---|
| Supplement containing Mitopure | Active comparator | Not described Receives: Dietary Supplement: Mitopure |
| Placebo Supplement | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma levels over time of creatine kinase (CK)
Muscle damage and recovery biomarker
Measured: 4 weeks
Change in race performance time during a 3000 m track race in elite runners
Measured: 4-weeks
Secondary outcomes (12)
Change from baseline in aerobic capacity (VO2max)
Measured: 4-weeks
Change from baseline in running economy via indirect calorimetry
Measured: 4-weeks
Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)
Measured: 4-weeks
Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)
Measured: 4-weeks
Change from baseline in Resting Metabolic Rate (RMR)
Measured: 4-weeks
Change from baseline in maximal muscle strength during 1-repetition maximum leg press
Measured: 4-weeks
change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)
only in sub-elite runners
Measured: 4-weeks
Change in acylcarnitines levels via metabolomics in plasma
Measured: 4-weeks
change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)
Measured: 4-weeks
change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)
Measured: 4-weeks
change in plasma levels of Urolithin A
Measured: 4-weeks
change in plasma levels of inflammatory marker CRP
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start21 Apr 2021
- Primary completion30 May 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Australian Catholic University
- Responsible party
- Sponsor
- Investigators
- Louise Burke, OAM PhD, Principal investigator, Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783207
- Sponsor's protocol ID
- 21.01.AMZ/ENDURO
- Acronym
- ENDURO
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitfield J, McKay AKA, Tee N, McCormick R, Morabito A, Karagounis LG, Fouassier AM, D'Amico D, Singh A, Burke LM, Hawley JA. Evaluating the Impact of Urolithin A Supplementation on Running Performance, Recovery, and Mitochondrial Biomarkers in Highly Trained Male Distance Runners. Sports Med. 2025 Dec;55(12):3183-3200. doi: 10.1007/s40279-025-02292-5. Epub 2025 Aug 21.
PubMed 40839339
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance in Athletes
- ClinicalTrials.gov ID
- NCT04783207
- Acronym / sponsor ID
- ENDURO / 21.01.AMZ/ENDURO
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Australian Catholic University
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement containing Mitopure | Active comparator | Dietary Supplement: Mitopure |
| Placebo Supplement | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-40 years
- Participants will be running >100 km/week
- Elite participants will be required to have a 3,000 m running personal best time below 9:00 (mm:ss), and/or a VO2max result greater than 65 ml·kg-1·min-1
- The sub-elite cohort will have a 3,000 m running personal best faster than 10:00 min and/or a VO2max >60 ml·kg-1·min-1
- Agree to participate in one of two ~4 week training camps been held between March-October 2021.
Key exclusion criteria (2 listed)
- Subjects with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
- Subjects who are unable to complete the training or testing protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitopureSoftgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily | Dietary supplement | Supplement containing Mitopure |
| PlaceboSoftgel containing only excipients. 4 soft-gels to be taken daily | Dietary supplement | Placebo Supplement |
Primary outcome
Change in plasma levels over time of creatine kinase (CK)
Time frame: 4 weeks
Muscle damage and recovery biomarker
Change in race performance time during a 3000 m track race in elite runners
Time frame: 4-weeks
12 secondary outcomes
Change from baseline in aerobic capacity (VO2max)
Time frame: 4-weeks
Change from baseline in running economy via indirect calorimetry
Time frame: 4-weeks
Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)
Time frame: 4-weeks
Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)
Time frame: 4-weeks
Change from baseline in Resting Metabolic Rate (RMR)
Time frame: 4-weeks
Change from baseline in maximal muscle strength during 1-repetition maximum leg press
Time frame: 4-weeks
change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)
Time frame: 4-weeks
Change in acylcarnitines levels via metabolomics in plasma
Time frame: 4-weeks
change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)
Time frame: 4-weeks
change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)
Time frame: 4-weeks
change in plasma levels of Urolithin A
Time frame: 4-weeks
change in plasma levels of inflammatory marker CRP
Time frame: 4-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 40839339Whitfield J, McKay AKA, Tee N, McCormick R, Morabito A, Karagounis LG, Fouassier AM, D'Amico D, Singh A, Burke LM, Hawley JA. Evaluating the Impact of Urolithin A Supplementation on Running Performance, Recovery, and Mitochondrial Biomarkers in Highly Trained Male Distance Runners. Sports Med. 2025 Dec;55(12):3183-3200. doi: 10.1007/s40279-025-02292-5. Epub 2025 Aug 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Burke, OAM PhD principal investigator
Australian Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure in people with Healthy, run by Amazentis SA at 1 site in Australia.
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 6 inclusion and 2 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 31 Aug 2023. 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 Australia. 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 plasma levels over time of creatine kinase (CK) (time frame: 4 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 NCT04783207, 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 31 Aug 2023.