Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID04985630

Open-labelled Study to Validate Home Use of a Health and Wellness Kit to Detect Urolithin A Levels in Dried Blood Spots After Mitopure Intake

Led by Amazentis SA · Updated on 2025-09-08

250

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 80 years
  • General good health as determined by the research team
  • Willingness to consume the study product and complete questionnaires
  • Voluntary electronic informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the trial
  • Planning to donate blood during or within 30 days after the study
  • Known allergy to active or inactive ingredients of the test material
  • Unstable medical conditions
  • Participation in another clinical trial within 30 days prior
  • Allergy or sensitivity to study ingredients
  • Cognitive impairment or inability to give informed consent
  • Any condition posing risk or affecting study completion as judged by the investigator
  • Antibiotic use within the previous 30 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Mitopure Challenge

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

Trial Site Locations

Total: 1 location

1

Amazentis USA

San Francisco, California, United States, 94111

Actively Recruiting

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Research Team

J

Julie Faitg, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Published Research Related To This Trial

Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population.

Anurag Singh, Davide D'Amico, Pénélope A Andreux...

https://pubmed.ncbi.nlm.nih.gov/34117375