Recruiting NCT04985630
The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mitopure, Pomegranate Juice.
- Who it may be relevant to
- Registry conditions: Healthy Aging, Healthy, Healthy Diet. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
Interventions
- Dietary supplement Mitopure
Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) - Dietary supplement Pomegranate Juice
100% Pomegranate juice
Primary outcome measures
- Failure/rejection rate (% of the samples) collected at home by participants. [Time frame: 4 weeks]
Secondary outcome measures (3)
- Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots. [Time frame: 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 [Time frame: 4 weeks]
- Validation of a health questionnaire on participants health status [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Amazentis USA — San Francisco
Publications
- Singh A, D'Amico D, Andreux PA, Dunngalvin G, Kern T, Blanco-Bose W, Auwerx J, Aebischer P, Rinsch C. Direct supplementation with Urolithin A overcomes limitations of dietary exposure and gut microbiome variability in healthy adults to achieve consistent levels across the population. Eur J Clin Nutr. 2022 Feb;76(2):297-308. doi: 10.1038/s41430-021-00950-1. Epub 2021 Jun 11. PMID 34117375
Identifiers
NCT: NCT04985630 · 21.02.AMZ