Assessing Urolithin A Levels in Home-Collected Blood Samples
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)
This study is testing how well people can collect their own blood samples at home to see if a supplement or pomegranate juice can help measure levels of Urolithin A, which might be important for healthy aging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Amazentis SA Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04985630 on ClinicalTrials.gov |
What this trial studies
This open-label, virtual home-based study aims to evaluate the repeatability of testing and the failure/rejection rates of dried blood spot samples collected by participants. Participants will consume Mitopure or pomegranate juice and complete questionnaires to provide data on their health and dietary habits. The study focuses on individuals aged 18 to 80 who are in general good health and willing to engage in the study process. The goal is to gather reliable data on Urolithin A levels, which may be linked to healthy aging.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 80 who are willing to participate in the study and consume the investigational product.
Not a fit: Patients who are pregnant, breastfeeding, or have unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of Urolithin A in promoting healthy aging and dietary health.
How similar studies have performed: While this approach is relatively novel, similar studies assessing dietary supplements and their effects on health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females 18 to 80 years of age; 2. Is in general good health, as determined by the research team; 3. Willingness to consume the investigation product, complete questionnaires and to complete the study; 4. Have given voluntary, electronic, informed consent to be a participant in the study. Exclusion Criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial; 2. Volunteers who plan to donate blood during the study or within 30 days of completing the study; 3. Subject has a known allergy to the test material's active or inactive ingredients; 4. Subjects with unstable medical conditions; 5. Participation in a clinical research trial within 30 days prior to randomization; 6. Allergy or sensitivity to study ingredients; 7. Individuals who are cognitively impaired and/or who are unable to give informed consent; 8. 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; 9. Has taken antibiotics within the previous 30 days.
Where this trial is running
San Francisco, California
- Amazentis USA — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Anurag Singh, MD, PhD — Amazentis SA
- Study coordinator: Julie Faitg, PhD
- Email: jfaitg@amazentis.com
- Phone: +41215521272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.