Urolithin A Supplementation to Boost Immune Health

Aging Clinical Trial

Official title:

Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05735886
• Other study ID #: 22.03.AMZ
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aging

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