Muscle Function, Mitochondrial FunctionATLASNCT03464500
AMAZ-02 Effect on Exercise ToLerance in Healthy, Overweight Middle Aged Subjects (ATLAS Trial)
A study testing Mitopure 500mg and Mitopure 1000mg in people with Muscle Function, Mitochondrial Function and Overweight, run by Amazentis SA at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Function, Mitochondrial Function, Overweight, Healthy Aging
- What is being tested?
- Mitopure 500mg and Mitopure 1000mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of AMAZ-02 on Muscle Function in Otherwise Healthy Middle-aged, Overweight and Inactive Individuals
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.
- Being tested
- Mitopure 500mg, Mitopure 1000mg, Placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure 500mgDietary supplement
Mitopure containing softgels
Mitopure 1000mgDietary supplement
Mitopure containing softgels
PlaceboDietary supplement
Placebo containing softgels
| Study group | Role | What they receive |
|---|---|---|
| Mitopure 500mg | Active comparator | Not described Receives: Dietary Supplement: Mitopure 500mg |
| Mitopure 1000mg | Active comparator | Not described Receives: Dietary Supplement: Mitopure 1000mg |
| Placebo | Active comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2, 4 months
Change in distance walked in the 6-minute walk test as a measure of aerobic endurance from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 4 months
Change in gait speed from baseline to day 120 between AMAZ-02 groups and placebo as derived from the 6-minute walk test
Measured: 4 months
Change in the 30-second chair stand test from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 4 months
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's quality of life as assessed by the 36-item short form (SF-36) questionnaire
Measured: 4 months
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's perceived exertion during exercise testing as assessed by the Borg Rating of Perceived Exertion Scale (Scale from 6-20)
Measured: 2, 4 months
Change from baseline to days 60 and 120 between AMAZ-02 groups and placebo in participant' resting energy expenditure in Kcal/ day via the Cardiocoach CO2 system
Measured: 2, 4 months
Change in 3-day food records reviewed at baseline and days 60 and 120
Measured: 2, 4 months
Change from baseline to day 60 and from baseline to day 120 in serum lipid profile, insulin, and HbA1C between AMAZ-02 groups and placebo
Measured: 2, 4 months
Change in lean body mass as assessed by dual X-ray absorptiometry (DXA) from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 4 months
Change in acylcarnitine profile in plasma via Metabolomics assessments from baseline to day 60, and from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 2, 4 months
Change in plasma muscle function biomarkers (myostatin, follistatin, inflammatory cytokines and mitokines) from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo
Measured: 2, 4 months
Change in in vivo mitochondrial gene expression from baseline to day 120 between AMAZ-02 groups and placebo as assessed via microarray performed on muscle biopsy
Measured: 4 months
Change in the gut microbial diversity at baseline and at day 120 between AMAZ-02 groups and placebo assessed via 16s RNA sequencing performed on fecal samples
Measured: 4 months
The change in the international physical activity questionnaire score (IPAQ) from baseline to day 120 between AMAZ-02 500mg/d and 1000mg/d and placebo.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start6 Mar 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Function, Mitochondrial FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Mal Evans, PhD, Study director, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464500
- Sponsor's protocol ID
- 18AMHA / 17.02.AMZ
- Acronym
- ATLAS
- Status last verified
- Oct 2019
- First submitted
- 5 Feb 2018
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35584623
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of AMAZ-02 on Muscle Function in Otherwise Healthy Middle-aged, Overweight and Inactive Individuals
- ClinicalTrials.gov ID
- NCT03464500
- Acronym / sponsor ID
- ATLAS / 18AMHA / 17.02.AMZ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitopure 500mg | Active comparator | Dietary Supplement: Mitopure 500mg |
| Mitopure 1000mg | Active comparator | Dietary Supplement: Mitopure 1000mg |
| Placebo | Active comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Body mass index (BMI) between 25.0 and 34.9 kg/m2, inclusive
Key exclusion criteria (45 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitopure 500mgMitopure containing softgels | Dietary supplement | Mitopure 500mg |
| Mitopure 1000mgMitopure containing softgels | Dietary supplement | Mitopure 1000mg |
| PlaceboPlacebo containing softgels | Dietary supplement | Placebo |
Primary outcome
Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 4 months
19 secondary outcomes
Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 60 between AMAZ-02 groups and placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2, 4 months
Change in distance walked in the 6-minute walk test as a measure of aerobic endurance from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 4 months
Change in gait speed from baseline to day 120 between AMAZ-02 groups and placebo as derived from the 6-minute walk test
Time frame: 4 months
Change in the 30-second chair stand test from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 4 months
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's quality of life as assessed by the 36-item short form (SF-36) questionnaire
Time frame: 4 months
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's perceived exertion during exercise testing as assessed by the Borg Rating of Perceived Exertion Scale (Scale from 6-20)
Time frame: 2, 4 months
Change from baseline to days 60 and 120 between AMAZ-02 groups and placebo in participant' resting energy expenditure in Kcal/ day via the Cardiocoach CO2 system
Time frame: 2, 4 months
Change in 3-day food records reviewed at baseline and days 60 and 120
Time frame: 2, 4 months
Change from baseline to day 60 and from baseline to day 120 in serum lipid profile, insulin, and HbA1C between AMAZ-02 groups and placebo
Time frame: 2, 4 months
Change in lean body mass as assessed by dual X-ray absorptiometry (DXA) from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 4 months
Change in acylcarnitine profile in plasma via Metabolomics assessments from baseline to day 60, and from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 2, 4 months
Change in plasma muscle function biomarkers (myostatin, follistatin, inflammatory cytokines and mitokines) from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo
Time frame: 2, 4 months
Change in in vivo mitochondrial gene expression from baseline to day 120 between AMAZ-02 groups and placebo as assessed via microarray performed on muscle biopsy
Time frame: 4 months
Change in the gut microbial diversity at baseline and at day 120 between AMAZ-02 groups and placebo assessed via 16s RNA sequencing performed on fecal samples
Time frame: 4 months
The change in the international physical activity questionnaire score (IPAQ) from baseline to day 120 between AMAZ-02 500mg/d and 1000mg/d and placebo.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 35584623Singh 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mal Evans, PhD study director
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure 500mg and Mitopure 1000mg in people with Muscle Function, Mitochondrial Function and Overweight, run by Amazentis SA at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.