Clinical trial NCT05735886: Urolithin A Supplementation to Boost Immune Health
Official title: Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Immune system
mitochondria
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: Goethe University
First posted: 2023-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in percentages of CD3+ T-cell immune cell population
timeFrame: 28 days
measure: Change in Mitochondrial activity in CD3+ T-cells
timeFrame: 28 days
Secondary outcomes:
measure: Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation
timeFrame: 28 days
measure: Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry
timeFrame: 28 days
measure: Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry
timeFrame: 28 days
measure: Change in gene-expression: single cell analysis of CD3+ T-cells
timeFrame: 28 days
measure: Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation
timeFrame: 28 days
measure: Change in Lipid profile
timeFrame: 28 days
measure: Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)
timeFrame: 28 days
measure: Number of adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany
Study officials:
affiliation: Universitätsklinikum Frankfurt Medizinische Klinik I
name: Dr. Dominic Denk, MD
role: PRINCIPAL_INVESTIGATOR
References: