Urolithin A Supplementation to Boost Immune Health
- Conditions
- Aging
- Interventions
- Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure)Dietary Supplement: Softgel containing placebo
- Registration Number
- NCT05735886
- Lead Sponsor
- Amazentis SA
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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 would compromise the study outcome or the safety of the research participant
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 informed consent
- Any 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
- 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 per the 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Urolithin A (Mitopure) Softgel containing 250mg of Urolithin A (Mitopure) - Placebo Softgel containing placebo -
- Primary Outcome Measures
Name Time Method Change in Mitochondrial activity in CD3+ T-cells 28 days Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
Change in percentages of CD3+ T-cell immune cell population 28 days In particular, number of CD8+ T memory stem cells (identified by expression of CD8+CD45RA+CCR7+CD95+) and naïve-like T cells (CD8+CD45RA+CCR7+CD95-)
- Secondary Outcome Measures
Name Time Method Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation 28 days Change in gene-expression: single cell analysis of CD3+ T-cells 28 days Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation 28 days Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry 28 days Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry 28 days Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age) 28 days Change in Lipid profile 28 days Number of adverse events 28 days
Trial Locations
- Locations (1)
Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany
🇩🇪Frankfurt, Germany