AMAZ-02 Effect on Exercise ToLerance in Healthy, Overweight Middle Aged Subjects (ATLAS Trial)

NCT03464500 | Completed

• 1 other identifier: 18AMHA / 17.02.AMZ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 of age, who are otherwise healthy. AMAZ-02, a food derived ingredient, will be given as a daily oral dose for 4 months.

Conditions

Muscle Function, Mitochondrial Function; Overweight; Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo

  4 months

Secondary Outcomes (19)

• Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 60 between AMAZ-02 groups and placebo

  2 months

• Change in exercise tolerance as assessed by time to fatigue on the cycle ergometer from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo

  2, 4 months

• Change in handgrip strength of the non-dominant hand as assessed by Jamar dynamometry from baseline to day 120 between AMAZ-02 groups and placebo

  4 months

• Change in isokinetic lower body muscle strength as assessed by the Biodex isokinetic dynamometer from baseline to day 120 between AMAZ-02 groups and placebo

  4 months

• Change in physical performance on the cycle ergometry defined as the time to reach 85% of maximum heart rate from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo

  2, 4 months

Study Arms (3)

Mitopure 500mg

ACTIVE COMPARATOR

Dietary Supplement: Mitopure 500mg

Mitopure 1000mg

ACTIVE COMPARATOR

Dietary Supplement: Mitopure 1000mg

Placebo

ACTIVE COMPARATOR

Dietary Supplement: Placebo

Interventions

Mitopure 500mg DIETARY_SUPPLEMENT

Mitopure containing softgels

Mitopure 500mg

Mitopure 1000mg DIETARY_SUPPLEMENT

Mitopure containing softgels

Mitopure 1000mg

Placebo DIETARY_SUPPLEMENT

Placebo containing softgels

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amazentis SA: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• Singh A, D'Amico D, Andreux PA, Fouassier AM, Blanco-Bose W, Evans M, Aebischer P, Auwerx J, Rinsch C. Urolithin A improves muscle strength, exercise performance, and biomarkers of mitochondrial health in a randomized trial in middle-aged adults. Cell Rep Med. 2022 May 17;3(5):100633. doi: 10.1016/j.xcrm.2022.100633.

  PMID: 35584623 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mal Evans, PhD

  KGK Science Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 14, 2018
• Study Start: March 6, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 17, 2022

Record last verified: 2019-10

Locations

CA (1)