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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283462
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
University of Washington
Synteract, Inc.
Information provided by (Responsible Party):
Amazentis SA

Brief Summary:
This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling 77 healthy elderly subjects (38-40 placebo and 38-40 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.

Condition or disease Intervention/treatment Phase
Mitochondrial Function, Bioenergetics Muscle Function Aging Dietary Supplement: AMAZ-02 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : October 30, 2020

Arm Intervention/treatment
Active Comparator: AMAZ-02 Dietary Supplement: AMAZ-02
AMAZ-02 containing softgels

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo containing softgels




Primary Outcome Measures :
  1. Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy) [ Time Frame: 4 months ]
  2. Percent change from baseline in contraction number during a hand muscle fatigue test [ Time Frame: 2, 4 months ]

Secondary Outcome Measures :
  1. Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS) [ Time Frame: 4 months ]
  2. Percent change from baseline in contraction number during a leg muscle fatigue test [ Time Frame: 4 months ]
  3. Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline [ Time Frame: 4 months ]
  4. Change in exercise tolerance compared to baseline (via cycle ergometry) [ Time Frame: 4 months ]
  5. Change in hand grip strength at the end of study intervention compared to baseline [ Time Frame: 4 months ]
  6. Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline [ Time Frame: 4 months ]
  7. Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline [ Time Frame: 4 months ]
  8. Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline [ Time Frame: 4 months ]
  9. Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry) [ Time Frame: 4 months ]
  10. Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue [ Time Frame: 4 months ]
  11. Effect of AMAZ-02 on plasma acylcarnitines [ Time Frame: 4 months ]
  12. Effect of AMAZ-02 on quality of life questionnaire (SF36) [ Time Frame: 4 months ]
  13. Change from baseline in plasma lipid profile [ Time Frame: 4 months ]
  14. Change from baseline in plasma for circulating biomarkers (myostatin, follistatin) [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults ≥65 and ≤90 years of age
  2. Able to travel to and from the University of Washington and Fred Hutch Cancer Research Center (FHCRC)
  3. Informed consent obtained
  4. 6 minute walk distance of <550 meters
  5. ATP max < 1mM /sec (in the hand FDI muscle)

Exclusion Criteria:

  1. 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
  2. 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.
  3. Have any metal implants in the right limbs, including non-MRI compatible metal stents, titanium pins/markers, etc.
  4. Have an implanted cardiac pacemaker or other implanted non-MRI compatible cardiac device
  5. 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.
  6. Body mass index <18 or >32 kg/m2
  7. Severe chronic kidney disease requiring treatment with hemodialysis or peritoneal dialysis.
  8. Additional laboratory abnormalities determined as clinically significant by the Investigator.
  9. Clinically significant abnormalities on physical examination (as judged by the Investigator)
  10. Clinically significant and chronic uncontrolled renal, hepatic, pulmonary, endocrine, neurologic disorders, bone, or gastrointestinal system dysfunction
  11. History of seizures or epilepsy
  12. History of serious mental illness as judged by the Investigator
  13. Oral temperature >37.5°C at the time of the physical
  14. Suspicion, or recent history, of alcohol or substance abuse or tobacco use
  15. 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.
  16. 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
  17. 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
  18. 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
  19. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283462


Contacts
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Contact: Anurag Singh, MD, PhD +41215521274 asingh@amazentis.com

Locations
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United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Dave Marcinek, PhD    206-221-6785    dmarc@uw.edu   
Sponsors and Collaborators
Amazentis SA
University of Washington
Synteract, Inc.
Investigators
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Principal Investigator: David Marcinek, PhD University of Washington
Principal Investigator: Jose Garcia, MD VA Puget Sound Health Care System
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Responsible Party: Amazentis SA
ClinicalTrials.gov Identifier: NCT03283462    
Other Study ID Numbers: 17.01.AMZ
1178231 ( Other Identifier: WIRB )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No