Health TrialsbyHealthPanel

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

ConditionsHealthy AgingHealthyHealthy Diet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmazentis SA

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Mitopure

    Dietary supplement

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

  • Pomegranate Juice

    Dietary supplement

    100% Pomegranate juice

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intakeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Failure/rejection rate (% of the samples) collected at home by participants.

Acceptability target goal is to hit 80% of analyzed samples

Time frame
4 weeks

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amazentis SA

Lead sponsor

Source ClinicalTrials.gov
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