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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05735886
Other study ID # 22.03.AMZ
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date May 31, 2024

Study information

Verified date March 2024
Source Amazentis SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date May 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Softgel containing placebo
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Softgel containing 250mg of Urolithin A (Mitopure)
Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days

Locations

Country Name City State
Germany Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany Frankfurt

Sponsors (2)

Lead Sponsor Collaborator
Amazentis SA Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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-) 28 days
Primary Change in Mitochondrial activity in CD3+ T-cells Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse 28 days
Secondary 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
Secondary Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry 28 days
Secondary Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry 28 days
Secondary Change in gene-expression: single cell analysis of CD3+ T-cells 28 days
Secondary Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation 28 days
Secondary Change in Lipid profile 28 days
Secondary Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age) 28 days
Secondary Number of adverse events 28 days
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