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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04783207