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Led by Amazentis SA · Updated on 2025-09-08
250
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are conducting an open-labelled, virtual home-based study to evaluate the repeatability and failure or rejection rates of blood samples collected at home by participants. The study focuses on healthy adults aged 18 to 80 years and aims to measure levels of Urolithin A, a compound linked to healthy aging, in dried blood spots. The trial is sponsored by Amazentis SA and involves assessing the impact of dietary intake and supplementation on blood levels of Urolithin A. Participants will undergo a Mitopure challenge that includes consuming pomegranate juice followed by Mitopure supplementation, a proprietary Urolithin A dietary supplement provided as fruit-flavored sachets. Blood samples will be collected at home before and after the challenge to compare UA-Glucuronide levels. The study also involves completing health questionnaires to validate participants health status related to the intervention. During the study, participants will collect dried blood spot samples at home over a 4-week period, which researchers will analyze for failure rates and sensitivity of the testing method. Participants will complete health questionnaires and monitor their intake of the study products. The research team aims to validate the home-based collection method and assess changes in Urolithin A levels, with all activities conducted in a virtual, participant-friendly setting.
CONDITIONS
The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots
J
Julie Faitg, PhD
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Amazentis SA
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Mitopure Supplement (Urolithin A) | Dietary Exposure / Pomegranate Juice |
|---|---|---|
| What it is | A fruit-flavored sachet containing a fixed proprietary dose of Mitopure (Urolithin A), given along with controlled dietary and pomegranate juice intake, with Urolithin A levels measured in dried blood spots. | Natural dietary intake of Urolithin A precursors, mainly through foods like pomegranate juice or related fruits, without standardized supplementation. |
| Role in trial | Only assigned study group; all participants receive the Mitopure supplement regardless of background diet. | Background context for comparison; not assigned by the trial, but reflects widespread nutritional practice outside of supplementation. |
| Primary use | To measure whether controlled supplementation with Mitopure increases blood levels of Urolithin A in healthy adults compared to baseline and natural dietary exposure. | To naturally increase or provide Urolithin A exposure via usual diet or pomegranate juice; effectiveness depends on individual microbiome. |
| How it is given or performed | Participants consume Mitopure sachets and pomegranate juice as instructed, collect their own dried blood spot samples at home, and return them for laboratory analysis. | Dietary intake of foods containing Urolithin A precursors, primarily through drinking pomegranate juice; no standardized dose, frequency, or self-collection component. |
| Evidence status | Study ongoing; no published results for this trial yet. External evidence supports Mitopure's ability to increase Urolithin A blood levels, overcoming limitations seen with diet alone. | Published studies show that natural dietary intake, including pomegranate juice, results in inconsistent and often low blood Urolithin A levels due to differences in individual microbiome composition. |
| Important limitations | Single-group design means findings are compared to dietary background rather than to a randomized control. Results depend on participant adherence and accuracy of at-home blood sampling. Long-term effects and safety are not yet established. | Ability to increase Urolithin A through diet or juice alone is highly variable. Many healthy adults are 'non-producers', gaining little to no increase despite increased intake. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 4 weeks
Participants consume Pomegranate juice followed by Mitopure supplementation to assess blood levels of Urolithin A using dried blood spots collected at home.
Home sample collections as per kit instructions
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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Anurag Singh, Davide D'Amico, Pénélope A Andreux...
https://pubmed.ncbi.nlm.nih.gov/34117375/Amazentis SA
Lead Sponsor
