Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04783207




Registration number
NCT04783207
Ethics application status
Date submitted
5/02/2021
Date registered
5/03/2021
Date last updated
31/08/2023

Titles & IDs
Public title
Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
Scientific 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
Secondary ID [1] 0 0
21.01.AMZ/ENDURO
Universal Trial Number (UTN)
Trial acronym
ENDURO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Mitopure
Treatment: Other - Placebo

Active comparator: Supplement containing Mitopure -

Placebo comparator: Placebo Supplement -


Treatment: Other: Mitopure
Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily

Treatment: Other: Placebo
Softgel containing only excipients. 4 soft-gels to be taken daily
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in plasma levels over time of creatine kinase (CK)
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Change in race performance time during a 3000 m track race in elite runners
Timepoint [2] 0 0
4-weeks
Secondary outcome [1] 0 0
Change from baseline in aerobic capacity (VO2max)
Timepoint [1] 0 0
4-weeks
Secondary outcome [2] 0 0
Change from baseline in running economy via indirect calorimetry
Timepoint [2] 0 0
4-weeks
Secondary outcome [3] 0 0
Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)
Timepoint [3] 0 0
4-weeks
Secondary outcome [4] 0 0
Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)
Timepoint [4] 0 0
4-weeks
Secondary outcome [5] 0 0
Change from baseline in Resting Metabolic Rate (RMR)
Timepoint [5] 0 0
4-weeks
Secondary outcome [6] 0 0
Change from baseline in maximal muscle strength during 1-repetition maximum leg press
Timepoint [6] 0 0
4-weeks
Secondary outcome [7] 0 0
change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)
Timepoint [7] 0 0
4-weeks
Secondary outcome [8] 0 0
Change in acylcarnitines levels via metabolomics in plasma
Timepoint [8] 0 0
4-weeks
Secondary outcome [9] 0 0
change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)
Timepoint [9] 0 0
4-weeks
Secondary outcome [10] 0 0
change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)
Timepoint [10] 0 0
4-weeks
Secondary outcome [11] 0 0
change in plasma levels of Urolithin A
Timepoint [11] 0 0
4-weeks
Secondary outcome [12] 0 0
change in plasma levels of inflammatory marker CRP
Timepoint [12] 0 0
4-weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2023
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australian Catholic University/Australian Institute of Sports - Canberra
Recruitment postcode(s) [1] 0 0
- Canberra

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amazentis SA
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Catholic University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04783207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Louise Burke, OAM PhD
Address 0 0
Australian Catholic University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04783207