Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
Completed · Not applicable
Conditions studied: Healthy, Healthy Aging
In brief
This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice
Key facts
- Study ID
- NCT04160312
- Run by
- Amazentis SA
- People needed
- 100
- Starts
- 2019-11-08
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2020-04-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males and females 18 to 80 years of age;
- Is in general good health, as determined by the clinical research team;
- Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
- Have given voluntary, written, informed consent to participant in the study;
You may not qualify if…
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- Alcohol or drug abuse within the last 6 months;
- 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;
- Clinically significant abnormal laboratory results at screening;
- Participation in a clinical research trial within 30 days prior to randomization;
- Allergy or sensitivity to study ingredients; lactose intolerance.
- 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;
Where it is running
- Atlantia Food Clinical Trials CRO (Northwestern University campus) — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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