AgingNCT05735886
Urolithin A Supplementation to Boost Immune Health
A study testing Softgel containing 250mg of Urolithin A (Mitopure) in people with Aging, run by Amazentis SA at 1 site in Germany.
Trial summary
To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Softgel containing 250mg of Urolithin A (Mitopure)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2023to 31 Aug 2024
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)
- BMI<35kg/m2
- Provide informed consent
- Adults aged 45-70 years, both genders
- Subjects who have not received any systemic immunosuppression in the past 6 months
- Subjects with any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the research participant
Who cannot join
- Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any 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
Show all 11Show fewer
- Current gastrointestinal condition which could interfere with the study (e.g. IBS/IBD, diarrhea, acid reflux disease, dysphagia etc.);
- Excessive alcohol consumption and/or a smoker
- Concomitant use of statins
- Engage in regular moderate or vigorous physically activities (i.e. Category 3 as per the IPAQ activity classification)
- Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs), immune-boosting(Vitamin C, Zinc) or mitochondrial (COQ10, NAD+) supplements within 45 days prior to screening
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany
Frankfurt
About this study
Official title: Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function
- Conditions
- Aging
- Being tested
- Softgel containing placebo, Softgel containing 250mg of Urolithin A (Mitopure)
- Keywords
- Immune system, mitochondria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Softgel containing placeboDietary supplement
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Softgel containing 250mg of Urolithin A (Mitopure)Dietary supplement
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Softgel containing placebo |
| Urolithin A (Mitopure) | Active comparator | Not described Receives: Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentages of CD3+ T-cell immune cell population
In particular, number of CD8+ T memory stem cells (identified by expression of CD8+CD45RA+CCR7+CD95+) and naïve-like T cells (CD8+CD45RA+CCR7+CD95-)
Measured: 28 days
Change in Mitochondrial activity in CD3+ T-cells
Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
Measured: 28 days
Secondary outcomes (8)
Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation
Measured: 28 days
Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry
Measured: 28 days
Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry
Measured: 28 days
Change in gene-expression: single cell analysis of CD3+ T-cells
Measured: 28 days
Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation
Measured: 28 days
Change in Lipid profile
Measured: 28 days
Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)
Measured: 28 days
Number of adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jan 2023
- Primary completion31 Mar 2024
- Study completion31 Aug 2024
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Goethe University
- Responsible party
- Sponsor
- Investigators
- Dr. Dominic Denk, MD, Principal investigator, Universitätsklinikum Frankfurt Medizinische Klinik I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735886
- Sponsor's protocol ID
- 22.03.AMZ
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denk D, Singh A, Kasler HG, D'Amico D, Rey J, Alcober-Boquet L, Gorol JM, Steup C, Tiwari R, Kwok R, Arguello RJ, Faitg J, Sprinzl K, Zeuzem S, Nekljudova V, Loibl S, Verdin E, Rinsch C, Greten FR. Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial. Nat Aging. 2025 Nov;5(11):2309-2322. doi: 10.1038/s43587-025-00996-x. Epub 2025 Oct 31.
PubMed 41174221
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
- ClinicalTrials.gov ID
- NCT05735886
- Acronym / sponsor ID
- 22.03.AMZ
- Conditions
- Aging
- Keywords
- Immune system, mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Goethe University
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Feb 2023 (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.
To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Softgel containing placebo |
| Urolithin A (Mitopure) | Active comparator | Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)
- BMI<35kg/m2
- Provide informed consent
- Adults aged 45-70 years, both genders
- Subjects who have not received any systemic immunosuppression in the past 6 months
Key exclusion criteria (11 listed)
- Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
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 |
|---|---|---|
| Softgel containing placeboSingle oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days | Dietary supplement | Placebo |
| Softgel containing 250mg of Urolithin A (Mitopure)Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days | Dietary supplement | Urolithin A (Mitopure) |
Primary outcome
Change in percentages of CD3+ T-cell immune cell population
Time frame: 28 days
In particular, number of CD8+ T memory stem cells (identified by expression of CD8+CD45RA+CCR7+CD95+) and naïve-like T cells (CD8+CD45RA+CCR7+CD95-)
Change in Mitochondrial activity in CD3+ T-cells
Time frame: 28 days
Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
8 secondary outcomes
Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation
Time frame: 28 days
Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry
Time frame: 28 days
Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry
Time frame: 28 days
Change in gene-expression: single cell analysis of CD3+ T-cells
Time frame: 28 days
Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation
Time frame: 28 days
Change in Lipid profile
Time frame: 28 days
Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)
Time frame: 28 days
Number of adverse events
Time frame: 28 days
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 26 Sep 2024.
- Derived from this study: PubMed 41174221Denk D, Singh A, Kasler HG, D'Amico D, Rey J, Alcober-Boquet L, Gorol JM, Steup C, Tiwari R, Kwok R, Arguello RJ, Faitg J, Sprinzl K, Zeuzem S, Nekljudova V, Loibl S, Verdin E, Rinsch C, Greten FR. Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial. Nat Aging. 2025 Nov;5(11):2309-2322. doi: 10.1038/s43587-025-00996-x. Epub 2025 Oct 31.
- 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. This study is not recruiting at the moment.
Dr. Dominic Denk, MD principal investigator
Universitätsklinikum Frankfurt Medizinische Klinik I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Softgel containing 250mg of Urolithin A (Mitopure) in people with Aging, run by Amazentis SA at 1 site in Germany.
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 6 inclusion and 11 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 26 Sep 2024. 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 Germany. 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. Some participants in this study may receive a placebo. 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 percentages of CD3+ T-cell immune cell population (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT05735886, 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 26 Sep 2024.