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Recruiting

NCT Number: NCT04985630

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

Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amazentis USA

San Francisco, California, 94111, United States

Location status: Recruiting

Location contact

Anurag Singh, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Mitopure

Dietary Supplement

Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)

Pomegranate Juice

Dietary Supplement

100% Pomegranate juice

Primary outcomes

  1. 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

Secondary outcomes

  1. Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.

    Time frame: 4 weeks

  2. 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

  3. Validation of a health questionnaire on participants health status

    Time frame: 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Faitg, PhD

CONTACT

[email protected]

+41215521272

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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