No phaseCompleted
Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Impact of a Daily Dose of AMAZ-02, a Food Derived Ingredient, for 4 Months on Skeletal Muscle Energetics and Function in Healthy Elderly
- Sponsor
- Amazentis SA (Industry)
- Enrolment
- 66 enrolled
- Conditions
- Mitochondrial Function, Bioenergetics; Muscle Function; Aging
- Interventions
- Mitopure; Placebo
- Ages
- older adults
- Registry
- NCT03283462
From the registry
This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling 66 healthy elderly subjects (33 placebo and 33 AMAZ-02 administration) who are ≥65 and ≤ 90 years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally administered for 4 months.
Primary outcomes
- Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
- Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)