NCT03283462

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Amazentis SA · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Mitochondrial Function, Bioenergetics
• Muscle Function
• Aging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mitopure	Mitopure (Urolithin A) containing softgels
DIETARY_SUPPLEMENT	Placebo	Placebo containing softgels

Timeline

• Start date: 2018-02-15
• Primary completion: 2020-09-25
• Completion: 2020-10-28
• First posted: 2017-09-14
• Last updated: 2022-08-22

Locations

1 site across 1 country: United States