Aging
Conditions
Keywords
Immune system, mitochondria
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
Interventions
DIETARY_SUPPLEMENTSoftgel containing placebo
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
DIETARY_SUPPLEMENTSoftgel containing 250mg of Urolithin A (Mitopure)
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Sponsors
Goethe University
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
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 would compromise the study outcome or the safety of the research participant
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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-) |
| Change in Mitochondrial activity in CD3+ T-cells | 28 days | Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry | 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 pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation | 28 days |
| Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age) | 28 days |
| Number of adverse events | 28 days |
| Change in Lipid profile | 28 days |
| Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry | 28 days |
Countries
Germany
Outcome results
None listed