NCT04985630RecruitingNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Amazentis SA
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Failure/rejection rate (% of the samples) collected at home by participants.
Study Overview
Brief Summary
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake
Experimental
Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)
Intervention: Pomegranate Juice (Dietary Supplement)
Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake
Experimental
Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)
Intervention: Mitopure (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.(4 weeks)
- Validation of a health questionnaire on participants health status(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)
Investigators
Study Sites (1)
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