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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Placebo containing softgels
|
|
Active Comparator: Mitopure
|
Mitopure (Urolithin A) containing softgels
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline
Time Frame: 4 months
|
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
|
2, 4 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline in contraction number during a hand muscle fatigue test
Time Frame: 2, 4 months
|
2, 4 months
|
|
Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS)
Time Frame: 4 months
|
4 months
|
|
Percent change from baseline in contraction number during a leg muscle fatigue test
Time Frame: 4 months
|
4 months
|
|
Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline
Time Frame: 4 months
|
4 months
|
|
Change in exercise tolerance compared to baseline (via cycle ergometry)
Time Frame: 4 months
|
4 months
|
|
Change in hand grip strength at the end of study intervention compared to baseline
Time Frame: 4 months
|
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
|
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
|
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
|
4 months
|
|
Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue
Time Frame: 4 months
|
4 months
|
|
Effect of AMAZ-02 on plasma acylcarnitines
Time Frame: 4 months
|
4 months
|
|
Effect of AMAZ-02 on quality of life questionnaire (SF36)
Time Frame: 4 months
|
4 months
|
|
Change from baseline in plasma lipid profile
Time Frame: 4 months
|
4 months
|
|
Change from baseline in plasma for circulating biomarkers (myostatin, follistatin)
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: David Marcinek, PhD, University of Washington
- Principal Investigator: Jose Garcia, MD, VA Puget Sound Health Care System
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 17.01.AMZ
- 1178231 (Other Identifier: WIRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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