Mitochondrial Function, BioenergeticsNCT03283462
Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
A study testing Mitopure in people with Mitochondrial Function, Bioenergetics and Muscle Function, run by Amazentis SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Function, Bioenergetics, Muscle Function, Aging
- What is being tested?
- Mitopure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 28 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- 6 minute walk distance of <550 meters
- ATP max < 1mM /sec (in the hand FDI muscle)
Who cannot join
- 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
Show all 19Show fewer
- 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.
- Subjects who are either unwilling to agree to refrain from using or are found to be using supplementary antioxidant vitamins (e.g., Coenzyme Q10, resveratrol, L-carnitine) from 7 days prior to dosing and throughout the treatment period
- Subjects who are either unwilling to agree to refrain from using or are found to be using the following dietary restrictions (pomegranate juice, walnuts, pecans, strawberry, raspberry blackberry) from 7 days prior to dosing and throughout the treatment period
- Are currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated, within the last 30 days from a clinical trial involving an investigational product. If the previous investigational product has a long half life, 3 months or 5 half-lives (whichever is longer) should have passed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: 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
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.
- Being tested
- Mitopure, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitopureDietary supplement
Mitopure (Urolithin A) containing softgels
PlaceboDietary supplement
Placebo containing softgels
| Study group | Role | What they receive |
|---|---|---|
| Mitopure | Active comparator | Not described Receives: Dietary Supplement: Mitopure |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
Measured: 4 months
Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)
Measured: 2, 4 months
Secondary outcomes (14)
Percent change from baseline in contraction number during a hand muscle fatigue test
Measured: 2, 4 months
Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS)
Measured: 4 months
Percent change from baseline in contraction number during a leg muscle fatigue test
Measured: 4 months
Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline
Measured: 4 months
Change in exercise tolerance compared to baseline (via cycle ergometry)
Measured: 4 months
Change in hand grip strength at the end of study intervention compared to baseline
Measured: 4 months
Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline
Measured: 4 months
Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline
Measured: 4 months
Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry)
Measured: 4 months
Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue
Measured: 4 months
Effect of AMAZ-02 on plasma acylcarnitines
Measured: 4 months
Effect of AMAZ-02 on quality of life questionnaire (SF36)
Measured: 4 months
Change from baseline in plasma lipid profile
Measured: 4 months
Change from baseline in plasma for circulating biomarkers (myostatin, follistatin)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start15 Feb 2018
- Primary completion25 Sep 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial Function, BioenergeticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- David Marcinek, PhD, Principal investigator, University of WashingtonJose Garcia, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283462
- Sponsor's protocol ID
- 17.01.AMZ
- Other IDs
- 1178231
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2017
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35050355
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03283462
- Acronym / sponsor ID
- 17.01.AMZ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington, Synteract, Inc.
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitopure | Active comparator | Dietary Supplement: Mitopure |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
- 6 minute walk distance of <550 meters
- ATP max < 1mM /sec (in the hand FDI muscle)
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitopureMitopure (Urolithin A) containing softgels | Dietary supplement | Mitopure |
| PlaceboPlacebo containing softgels | Dietary supplement | Placebo |
Primary outcome
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
Time frame: 4 months
Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy)
Time frame: 2, 4 months
14 secondary outcomes
Percent change from baseline in contraction number during a hand muscle fatigue test
Time frame: 2, 4 months
Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS)
Time frame: 4 months
Percent change from baseline in contraction number during a leg muscle fatigue test
Time frame: 4 months
Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline
Time frame: 4 months
Change in exercise tolerance compared to baseline (via cycle ergometry)
Time frame: 4 months
Change in hand grip strength at the end of study intervention compared to baseline
Time frame: 4 months
Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline
Time frame: 4 months
Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline
Time frame: 4 months
Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry)
Time frame: 4 months
Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue
Time frame: 4 months
Effect of AMAZ-02 on plasma acylcarnitines
Time frame: 4 months
Effect of AMAZ-02 on quality of life questionnaire (SF36)
Time frame: 4 months
Change from baseline in plasma lipid profile
Time frame: 4 months
Change from baseline in plasma for circulating biomarkers (myostatin, follistatin)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Results publication: PubMed 35050355Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marcinek, PhD principal investigator
University of Washington
Jose Garcia, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure in people with Mitochondrial Function, Bioenergetics and Muscle Function, run by Amazentis SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.