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

Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:65 - 90
Start Date:January 15, 2018
End Date:July 31, 2019
Contact:Anurag Singh, MD, PhD

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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
60 healthy elderly subjects (30 placebo and 30 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.

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 0.8 mM/sec (in the hand 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

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

8. Additional laboratory abnormalities determined as clinically significant by the

9. Clinically significant abnormalities on physical examination (as judged by the

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

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
We found this trial at
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Phone: 206-543-3763
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
Seattle, WA
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