The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults

ConditionsHealthy Aging Muscle Function

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-65

SponsorAmazentis SA

About this trial

This is a randomised, double-blind, placebo-controlled, parallel study to assess the effects of Urolithin A (Mitopure®) supplementation on muscle strength and performance in healthy middle-aged adults. Participants will be randomized to consume Mitopure® (500 mg), Mitopure® (1000 mg), or placebo once daily for 6 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Be able to give written informed consent.

2. Be between 40 to 65 years of age, inclusive.

3. Has a BMI between 25.0 and 34.9 kg/m2.

4. Low physical activity levels as assessed by the International Physical Activity Questionnaire (IPAQ).

Disqualifiers

1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.

a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).

b. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.

c. Sexual partner(s) is/are exclusively female.

Trial design

Design model

Parallel

Treatments tested in this trial

Placebo
Dietary supplement
Placebo softgels
Mitopure® 500mg
Dietary supplement
Softgels providing 500 mg of Mitopure®
Mitopure® 1000mg
Dietary supplement
Softgels providing 1000 mg of Mitopure®

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: 500 mg Mitopure®Experimental treatment 1 intervention

Group C: 1000 mg Mitopure®Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum isokinetic knee flexion strength

Change in maximum isokinetic knee flexion strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

Time frame

6 months

Secondary outcomes

Maximum isokinetic knee flexion strength

Change in maximum isokinetic knee flexion strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

Time frame

4 months

Maximum isokinetic knee extension strength

Change in maximum isokinetic knee extension strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

Time frame

4, 6 months

Maximum isometric knee flexion strength

Change in maximum isometric knee flexion strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

Time frame

4, 6 months

Maximum isometric knee extension strength

Change in maximum isometric knee extension strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)

Time frame

4, 6 months

Other outcomes

Cardiovascular fitness (VO2max)

Change in cardiovascular fitness (VO2max) between Mitopure® groups and placebo measured by a graded exercise test (unit: mL/kg/min)

Time frame

4, 6 months

Physical capacity (time to exhaustion)

Change in physical capacity between Mitopure® groups and placebo measured by time to exhaustion during the graded exercise test (unit: minutes)

Time frame

4, 6 months

Physical capacity (maximum cycling distance)

Change in physical capacity between Mitopure® groups and placebo measured by maximum cycling distance during the graded exercise test (unit: meters)

Time frame

4, 6 months

Physical performance (30-second chair stand)

Change in physical performance between Mitopure® groups and placebo measured by the 30-second chair stand test (unit: repetitions)

Time frame

4, 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amazentis SA

Lead sponsor

Atlantia Food Clinical Trials

Collaborator

Source ClinicalTrials.gov

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