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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany
Frankfurt, Germany
Change in percentages of CD3+ T-cell immune cell population
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-)
Time frame: 28 days
Change in Mitochondrial activity in CD3+ T-cells
Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
Time frame: 28 days
Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation
Time frame: 28 days
Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry
Time frame: 28 days
Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry
Time frame: 28 days
Change in gene-expression: single cell analysis of CD3+ T-cells
Time frame: 28 days
Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation
Time frame: 28 days
Change in Lipid profile
Time frame: 28 days
Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)
Time frame: 28 days
Number of adverse events
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Time frame: 28 days