Urolithin A Supplementation to Boost Immune Health

Last updated: September 25, 2024
Sponsor: Amazentis SA
Overall Status: Completed

Phase

N/A

Condition

Aging

Treatment

Softgel containing 250mg of Urolithin A (Mitopure)

Softgel containing placebo

Clinical Study ID

NCT05735886
22.03.AMZ
  • Ages 45-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)

  • BMI<35kg/m2

  • Provide informed consent

  • Adults aged 45-70 years, both genders

  • Subjects who have not received any systemic immunosuppression in the past 6 months

  • Subjects with any medical condition that in the opinion of the investigators wouldcompromise the study outcome or the safety of the research participant

Exclusion

Exclusion Criteria:

Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;

  • 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

  • Individuals who are cognitively impaired and/or who are unable to give informedconsent

  • Any condition which in the Investigator's opinion may adversely affect the subject'sability to complete the study or its measures or which may pose significant risk tothe subject

  • Current gastrointestinal condition which could interfere with the study (e.g.IBS/IBD, diarrhea, acid reflux disease, dysphagia etc.);

  • Excessive alcohol consumption and/or a smoker

  • Concomitant use of statins

  • Engage in regular moderate or vigorous physically activities (i.e. Category 3 as perthe IPAQ activity classification)

  • Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine,whey protein supplements, casein or branched-chain amino acids (BCAAs),immune-boosting(Vitamin C, Zinc) or mitochondrial (COQ10, NAD+) supplements within 45 days prior to screening

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Softgel containing 250mg of Urolithin A (Mitopure)
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany

    Frankfurt,
    Germany

    Site Not Available

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