Urolithin A Supplementation to Boost Immune Health

NCT05735886 | Completed

• 1 other identifier: 22.03.AMZ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Aging

Keywords

Immune system; mitochondria

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Softgel containing placebo

Urolithin A (Mitopure)

ACTIVE COMPARATOR

Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure)

Interventions

Softgel containing placebo DIETARY_SUPPLEMENT

Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days

Placebo

Softgel containing 250mg of Urolithin A (Mitopure) DIETARY_SUPPLEMENT

Single oral dose administration (4 softgels) to be orally administered daily according to the randomization for 28 days

Urolithin A (Mitopure)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amazentis SA: lead
• Goethe University: collaborator

Study Sites (1)

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

Frankfurt, Germany

Location

Related Publications (1)

• Denk D, Singh A, Kasler HG, D'Amico D, Rey J, Alcober-Boquet L, Gorol JM, Steup C, Tiwari R, Kwok R, Arguello RJ, Faitg J, Sprinzl K, Zeuzem S, Nekljudova V, Loibl S, Verdin E, Rinsch C, Greten FR. Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial. Nat Aging. 2025 Nov;5(11):2309-2322. doi: 10.1038/s43587-025-00996-x. Epub 2025 Oct 31.

  PMID: 41174221 DERIVED

MeSH Terms

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Study Officials

• Dr. Dominic Denk, MD

  Universitätsklinikum Frankfurt Medizinische Klinik I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: January 30, 2023
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)