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

Study Overview
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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.

Official Title
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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)

Conditions
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Healthy Aging, Healthy, Healthy Diet

Intervention / Treatment
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* Dietary Supplement: Mitopure
* Dietary Supplement: Pomegranate Juice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake<br>Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL) | Dietary Supplement: Mitopure<br>* Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)<br>Dietary Supplement: Pomegranate Juice<br>* 100% Pomegranate juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure/rejection rate (% of the samples) collected at home by participants. | Acceptability target goal is to hit 80% of analyzed samples | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots. |  | 4 weeks | 
| 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 |  | 4 weeks | 
| Validation of a health questionnaire on participants health status |  | 4 weeks |