Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Mitopure
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement containing Mitopure<br> | Dietary Supplement: Mitopure<br>* Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily<br>|
| Placebo Comparator: Placebo Supplement<br> | Dietary Supplement: Placebo<br>* Softgel containing only excipients. 4 soft-gels to be taken daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma levels over time of creatine kinase (CK) | Muscle damage and recovery biomarker | 4 weeks | 
| Change in race performance time during a 3000 m track race in elite runners |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in aerobic capacity (VO2max) |  | 4-weeks | 
| Change from baseline in running economy via indirect calorimetry |  | 4-weeks | 
| Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA) |  | 4-weeks | 
| Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA) |  | 4-weeks | 
| Change from baseline in Resting Metabolic Rate (RMR) |  | 4-weeks | 
| Change from baseline in maximal muscle strength during 1-repetition maximum leg press |  | 4-weeks | 
| change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO) | only in sub-elite runners | 4-weeks | 
| Change in acylcarnitines levels via metabolomics in plasma |  | 4-weeks | 
| change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only) |  | 4-weeks | 
| change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only) |  | 4-weeks | 
| change in plasma levels of Urolithin A |  | 4-weeks | 
| change in plasma levels of inflammatory marker CRP |  | 4-weeks |