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Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)

NCT03283462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-08-22

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Mitopure

Mitopure (Urolithin A) containing softgels

DIETARY_SUPPLEMENT

Placebo

Placebo containing softgels

Sponsors & Collaborators

Principal Investigators

  • David Marcinek, PhD · University of Washington

  • Jose Garcia, MD · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-15
Primary Completion
2020-09-25
Completion
2020-10-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283462 on ClinicalTrials.gov