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

Amazentis

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Mitopure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04783207

21.01.AMZ/ENDURO

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Supplement containing Mitopure

Active Comparator group

Treatment:

Dietary Supplement: Mitopure

Placebo Supplement

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo