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OpenTrials
Completed

NCT Number: NCT05735886

Urolithin A Supplementation to Boost Immune Health

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

Completed

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Key information

Conditions

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frankfurt, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Softgel containing placebo

Dietary Supplement

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)

Dietary Supplement

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

Primary outcomes

  1. Change in percentages of CD3+ T-cell immune cell population

    Time frame: 28 days

    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-)

  2. Change in Mitochondrial activity in CD3+ T-cells

    Time frame: 28 days

    Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse

Secondary outcomes

  1. Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation

    Time frame: 28 days

  2. Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry

    Time frame: 28 days

  3. Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry

    Time frame: 28 days

  4. Change in gene-expression: single cell analysis of CD3+ T-cells

    Time frame: 28 days

  5. Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation

    Time frame: 28 days

  6. Change in Lipid profile

    Time frame: 28 days

  7. Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)

    Time frame: 28 days

  8. Number of adverse events

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Goethe University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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