Clinical trial NCT04783207: Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: Australian Catholic University
First posted: 2021-03-05
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Change in plasma levels over time of creatine kinase (CK)
timeFrame: 4 weeks
measure: Change in race performance time during a 3000 m track race in elite runners
timeFrame: 4-weeks
Secondary outcomes:
measure: Change from baseline in aerobic capacity (VO2max)
timeFrame: 4-weeks
measure: Change from baseline in running economy via indirect calorimetry
timeFrame: 4-weeks
measure: Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)
timeFrame: 4-weeks
measure: Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)
timeFrame: 4-weeks
measure: Change from baseline in Resting Metabolic Rate (RMR)
timeFrame: 4-weeks
measure: Change from baseline in maximal muscle strength during 1-repetition maximum leg press
timeFrame: 4-weeks
measure: change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)
timeFrame: 4-weeks
measure: Change in acylcarnitines levels via metabolomics in plasma
timeFrame: 4-weeks
measure: change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)
timeFrame: 4-weeks
measure: change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)
timeFrame: 4-weeks
measure: change in plasma levels of Urolithin A
timeFrame: 4-weeks
measure: change in plasma levels of inflammatory marker CRP
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Australian Catholic University/Australian Institute of Sports
Study officials:
affiliation: Australian Catholic University
name: Louise Burke, OAM PhD
role: PRINCIPAL_INVESTIGATOR
References: