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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283462
Recruitment Status : Active, not recruiting
First Posted : September 14, 2017
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
University of Washington
Synteract, Inc.
Information provided by (Responsible Party):
Amazentis SA

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 14, 2017
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE February 15, 2018
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy) [ Time Frame: 4 months ]
  • Percent change from baseline in contraction number during a hand muscle fatigue test [ Time Frame: 2, 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Percent change from baseline in ATP max 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 SPPB Scores at the end of study interevention 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 6 minute walking distance (6MWD) at the end of study intervention compared to baselinecompared 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Mitochondrial Function, Bioenergetics
  • Muscle Function
  • Aging
Intervention  ICMJE
  • Dietary Supplement: AMAZ-02
    AMAZ-02 containing softgels
  • Dietary Supplement: Placebo
    Placebo containing softgels
Study Arms  ICMJE
  • Active Comparator: AMAZ-02
    Intervention: Dietary Supplement: AMAZ-02
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
66
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
90
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03283462
Other Study ID Numbers  ICMJE 17.01.AMZ
1178231 ( Other Identifier: WIRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amazentis SA
Study Sponsor  ICMJE Amazentis SA
Collaborators  ICMJE
  • University of Washington
  • Synteract, Inc.
Investigators  ICMJE
Principal Investigator: David Marcinek, PhD University of Washington
Principal Investigator: Jose Garcia, MD VA Puget Sound Health Care System
PRS Account Amazentis SA
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP