Urolithin A Supplementation to Boost Immune Health

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

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 Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Softgel containing placebo; Dietary supplement: Softgel containing 250mg of Urolithin A (Mitopure)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Softgel containing placebo; Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days
Active Comparator: Urolithin A (Mitopure)	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Mitochondrial activity in CD3+ T-cells	Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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 percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry	28 days
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 Lipid profile	28 days
Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)	28 days
Number of adverse events	28 days

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: Goethe University
• Investigators: Principal Investigator: Dr. Dominic Denk, MD, Universitätsklinikum Frankfurt Medizinische Klinik I

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mitochondria; Immune system
• Other Study ID Numbers: 22.03.AMZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No