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

NCT03283462 | Completed

• 2 other identifiers: 17.01.AMZ1178231
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline

  4 months

• Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)

  2, 4 months

Secondary Outcomes (14)

• Percent change from baseline in contraction number during a hand muscle fatigue test

  2, 4 months

• Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS)

  4 months

• Percent change from baseline in contraction number during a leg muscle fatigue test

  4 months

• Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline

  4 months

• Change in exercise tolerance compared to baseline (via cycle ergometry)

  4 months

Study Arms (2)

Mitopure

ACTIVE COMPARATOR

Dietary Supplement: Mitopure

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Mitopure DIETARY_SUPPLEMENT

Mitopure (Urolithin A) containing softgels

Mitopure

Placebo DIETARY_SUPPLEMENT

Placebo containing softgels

Placebo

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults ≥65 and ≤90 years of age
• Able to travel to and from the University of Washington and Fred Hutch Cancer Research Center (FHCRC)
• Informed consent obtained
• minute walk distance of \<550 meters
• ATP max \< 1mM /sec (in the hand FDI muscle)

You may not qualify if:

• Subjects who have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the trial or may influence either the results of the trial or the subject's ability to participate in the trial
• Hospitalization within 3 months for major atherosclerotic events (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery and stroke) and for any hospitalization within 2 months.
• Have any metal implants in the right limbs, including non-MRI compatible metal stents, titanium pins/markers, etc.
• Have an implanted cardiac pacemaker or other implanted non-MRI compatible cardiac device
• Chronic, uncontrolled hypertension as judged by the Investigator (i.e., Baseline SBP \>150 mm Hg, DBP \>90 mm Hg) or a SBP \> 150 mm Hg or DBP \> 95 mm Hg at the time of screening or baseline. If the initial BP reading is above these values, the reading may be repeated one time within 20 minutes of the initial reading.
• Body mass index \<18 or \>32 kg/m2
• Severe chronic kidney disease requiring treatment with hemodialysis or peritoneal dialysis.
• Additional laboratory abnormalities determined as clinically significant by the Investigator.
• Clinically significant abnormalities on physical examination (as judged by the Investigator)
• Clinically significant and chronic uncontrolled renal, hepatic, pulmonary, endocrine, neurologic disorders, bone, or gastrointestinal system dysfunction
• History of seizures or epilepsy
• History of serious mental illness as judged by the Investigator
• Oral temperature \>37.5°C at the time of the physical
• Suspicion, or recent history, of alcohol or substance abuse or tobacco use
• Subjects who in the opinion of the Investigator have a clinically significant abnormal 12-lead ECG during the screening period. Presence of atrial fibrillation, varying degrees of AV block, existence of a left bundle branch block, or evidence of previous myocardial infarction.

Sponsors & Collaborators

• Amazentis SA: lead
• University of Washington: collaborator
• Synteract, Inc.: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Liu S, D'Amico D, Shankland E, Bhayana S, Garcia JM, Aebischer P, Rinsch C, Singh A, Marcinek DJ. Effect of Urolithin A Supplementation on Muscle Endurance and Mitochondrial Health in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2144279. doi: 10.1001/jamanetworkopen.2021.44279.

  PMID: 35050355 RESULT

Study Officials

• David Marcinek, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jose Garcia, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: February 15, 2018
• Primary Completion: September 25, 2020
• Study Completion: October 28, 2020
• Last Updated: August 22, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)