Healthy, Healthy Aging, Healthy Diet
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMitopure
Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
DIETARY_SUPPLEMENTPomegranate Juice
100% Pomegranate juice
Sponsors
Amazentis SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure/rejection rate (% of the samples) collected at home by participants. | 4 weeks | Acceptability target goal is to hit 80% of analyzed samples |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactJulie Faitg, PhD
Outcome results
None listed