NCT05735886Active, not recruitingNot Applicable
Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Amazentis SA
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Mitochondrial activity in CD3+ T-cells
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in Mitochondrial activity in CD3+ T-cells
Time Frame: 28 days
Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
Change in percentages of CD3+ T-cell immune cell population
Time Frame: 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 Outcomes
- 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)
Investigators
Study Sites (1)
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