Healthy AgingNCT04985630
The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots
A study testing Mitopure and Pomegranate Juice in people with Healthy Aging and Healthy, run by Amazentis SA at 1 site in United States.
Trial summary
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy, Healthy Diet
- What is being tested?
- Mitopure and Pomegranate Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 18 to 80 years of age;
- Is in general good health, as determined by the research team;
- Willingness to consume the investigation product, complete questionnaires and to complete the study;
- Have given voluntary, electronic, informed consent to be a participant in the study.
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- Subject has a known allergy to the test material's active or inactive ingredients;
- Subjects with unstable medical conditions;
- Participation in a clinical research trial within 30 days prior to randomization;
- Allergy or sensitivity to study ingredients;
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- Individuals who are cognitively impaired and/or who are unable to give informed consent;
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject;
- Has taken antibiotics within the previous 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Amazentis USA
San Francisco, California, 94111
Anurag Singh, MD, PhD
About this study
Official title: Open-labelled Study to Validate Home-based Use of a Health and Wellness Kit (The Mitopure Challenge) to Detect Levels of Urolithin A in Dried Blood Spots After Intake of Mitopure (Proprietary Urolithin A)
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
- Conditions
- Healthy Aging, Healthy, Healthy Diet
- Being tested
- Mitopure, Pomegranate Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitopureDietary supplement
Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
Pomegranate JuiceDietary supplement
100% Pomegranate juice
| Study group | Role | What they receive |
|---|---|---|
| Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake | Experimental | Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL) Receives: Dietary Supplement: Mitopure; Dietary Supplement: Pomegranate Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure/rejection rate (% of the samples) collected at home by participants.
Acceptability target goal is to hit 80% of analyzed samples
Measured: 4 weeks
Secondary outcomes (3)
Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.
Measured: 4 weeks
Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge
Measured: 4 weeks
Validation of a health questionnaire on participants health status
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start30 Aug 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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 Healthy AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, MD, PhD, Principal investigator, Amazentis SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985630
- Sponsor's protocol ID
- 21.02.AMZ
- Status last verified
- Sep 2025
- First submitted
- 13 Jul 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh A, D'Amico D, Andreux PA, Dunngalvin G, Kern T, Blanco-Bose W, Auwerx J, Aebischer P, Rinsch C. Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. Eur J Clin Nutr. 2022 Feb;76(2):297-308. doi: 10.1038/s41430-021-00950-1. Epub 2021 Jun 11.
PubMed 34117375
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labelled Study to Validate Home-based Use of a Health and Wellness Kit (The Mitopure Challenge) to Detect Levels of Urolithin A in Dried Blood Spots After Intake of Mitopure (Proprietary Urolithin A)
- ClinicalTrials.gov ID
- NCT04985630
- Acronym / sponsor ID
- 21.02.AMZ
- Conditions
- Healthy Aging, Healthy, Healthy Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Aug 2021 (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.
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake | Experimental | Dietary Supplement: Mitopure, Dietary Supplement: Pomegranate JuiceMitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 18 to 80 years of age;
- Is in general good health, as determined by the research team;
- Willingness to consume the investigation product, complete questionnaires and to complete the study;
- Have given voluntary, electronic, informed consent to be a participant in the study.
Key exclusion criteria (9 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- Subject has a known allergy to the test material's active or inactive ingredients;
- Subjects with unstable medical conditions;
- Participation in a clinical research trial within 30 days prior to randomization;
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 |
|---|---|---|
| MitopureFruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) | Dietary supplement | Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake |
| Pomegranate Juice100% Pomegranate juice | Dietary supplement | Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake |
Primary outcome
Failure/rejection rate (% of the samples) collected at home by participants.
Time frame: 4 weeks
Acceptability target goal is to hit 80% of analyzed samples
3 secondary outcomes
Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.
Time frame: 4 weeks
Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge
Time frame: 4 weeks
Validation of a health questionnaire on participants health status
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 34117375Singh A, D'Amico D, Andreux PA, Dunngalvin G, Kern T, Blanco-Bose W, Auwerx J, Aebischer P, Rinsch C. Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. Eur J Clin Nutr. 2022 Feb;76(2):297-308. doi: 10.1038/s41430-021-00950-1. Epub 2021 Jun 11.
- Individual participant dataSharing planned: No
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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.
Anurag Singh, MD, PhD principal investigator
Amazentis SA
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 and Pomegranate Juice in people with Healthy Aging and Healthy, run by Amazentis SA at 1 site in United States.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Faitg, PhD (+41215521272, jfaitg@amazentis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure/rejection rate (% of the samples) collected at home by participants. (time frame: 4 weeks). 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 NCT04985630, 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 8 Sep 2025.