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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2026-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Aging Healthy Healthy Diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake

Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)

Group Type EXPERIMENTAL

Mitopure

Intervention Type DIETARY_SUPPLEMENT

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

Pomegranate Juice

Intervention Type DIETARY_SUPPLEMENT

100% Pomegranate juice

Interventions

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Mitopure

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

Intervention Type DIETARY_SUPPLEMENT

Pomegranate Juice

100% Pomegranate juice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes