Status:
COMPLETED
AMAZ-02 Effect on Exercise ToLerance in Healthy, Overweight Middle Aged Subjects (ATLAS Trial)
Lead Sponsor:
Amazentis SA
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Muscle Function, Mitochondrial Function
Overweight
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
This is a Phase 2 randomized, double-blind, placebo-controlled study enrolling 90 healthy, overweight, middle aged subjects (30 placebo, 30 low dose and 30 high dose AMAZ-02 intervention), 40-65 years...
Eligibility Criteria
Inclusion
- Healthy males and females 40 to 65 years of age, inclusive
- Subjects who have not participated within the last 1 year in clinical trials focused on improving muscle function and physical performance
- Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or,
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner (shown successful as per appropriate follow-up)
- Body mass index (BMI) between 25.0 and 34.9 kg/m2, inclusive
- Agree to avoid exercising 24 hours prior to study visits and maintain low physical activity status for the duration of the trial
- Agree to refrain from consumption of pomegranate juice and walnuts from 2 weeks prior to baseline and through the study period
- Agree to limit consumption of raspberries, strawberries and cloudberries from 2 weeks prior to baseline and through the study period
- Agree to refrain from using NSAIDs for 7-days prior to and following muscle sample collection
- Good general health to perform exercise testing safely, as determined by the Qualified Investigator based on medical history, physical examination, ECG and laboratory results
- Low VO2max defined as \<35 ml/kg/min for males and \<31 ml/kg/min for females as assessed by a submaximal cycle ergometer test
- Comprehension of the nature and purpose of the study including possible risks and side effects, and ability to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safely and reliably in the opinion of the investigative site staff
- Has given voluntary, written, informed consent to participate in the study
Exclusion
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial
- Smokers or ex-smokers within the past 1 year from screening, including use of vaporizers or e-cigarettes
- Participation in another clinical study or receipt of an investigational drug within 60 days of the screening visit
- Blood donation within 1 month of baseline, as well as planned donation 1 month after end of study.
- Recent history (within the last 2 years) of alcohol or other substance abuse
- Use of medicinal marijuana.
- Unable to swallow capsules
- Regular participation in a structured exercise program with physical activity levels in Category 2 or higher defined as 20 min vigorous activity 3-times per week, moderate activity for 30 min 5 days per week or more
- Inability to abstain from intensive muscular effort
- Individuals who have engaged in 1 hour or more per week of resistance training in the past 3 months.
- Currently experiencing any medical condition that interferes with the ability to undergo physical strength testing during the study
- Recent participation in a weight loss diet, or loss \>5% of total body weight within 3 months of randomization
- Clinically significant abnormal laboratory results at screening
- Allergy or sensitivity to test product ingredients (or closely related compounds)
- Allergy to anesthetic (Xylocaine, lidocaine)
- Soy allergy
- Inability to abstain from the consumption of pomegranate juice or walnuts
- Inability to abstain from frequent consumption of raspberries, strawberries or cloudberries
- Excessive consumption of beverages containing xanthine bases (\>4 cups per day) such as coffee, tea, and cola
- Use of NHPs for the purposes of muscle building or function. Use of other NHPs must have been on a stable dosing regimen for at least a month prior to baseline and must maintain their current dosing regimen throughout the trial and must not begin taking any new NHPs throughout the trial; if the subject wishes to stop taking the NHP prior to beginning the trial they must do so at least 2 weeks prior to randomization.
- History of or current diagnosis of bleeding/blood disorder
- Use of oral anticoagulants (blood thinners), New Oral Anticoagulants (NOAC) or antiplatelet agents.
- Use of NSAID medications within one week before or after the needle muscle biopsy procedures.
- Use of steroid medications, current/recent (3 months) history of anabolic steroid, corticosteroid or estrogen use.
- Use of statins
- Use of thyroid medications.
- Asthma that has not been controlled with a stable regimen for a minimum of a year, or Asthma requiring the use of certain medications.
- Diagnosis of COPD
- Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain
- Metal fixation plates or screws from a previous surgery
- Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (i.e. terminal illnesses)
- Diagnosis of active cardiac or peripheral vascular disease
- SBP/DBP ≥150/95 mmHg without the use of hypertension medications, or SBP/DBP \>140/90 mmHg with the use of hypertension medications.
- Diagnosed hyperlipidemia
- Renal or hepatic impairment or disease
- Any major diseases of the gastrointestinal, pulmonary or endocrine systems
- Type I and Type II diabetes
- Autoimmune disease or immuno-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
- Diagnosis of chronic infectious disease
- Diagnosis of phenylketonuria
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Participants with cancer in full remission for more than five years after diagnosis are acceptable if approved by QI.
- Significant neurological or psychiatric illness, including, but not limited to, Parkinson's disease and bipolar disorder as assessed by QI.
- History of seizures
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the qualified investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03464500
Start Date
March 6 2018
End Date
September 30 2019
Last Update
August 17 2022
Active Locations (1)
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1
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8