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Urolithin A Supplementation to Boost Immune Health

Sponsor
Amazentis SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05735886
Collaborator
Goethe University (Other)
50
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Softgel containing placebo
  • Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
Actual Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in percentages of CD3+ T-cell immune cell population [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 [28 days]

    Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse

Secondary Outcome Measures

  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 [28 days]

  2. Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry [28 days]

  3. Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry [28 days]

  4. Change in gene-expression: single cell analysis of CD3+ T-cells [28 days]

  5. Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation [28 days]

  6. Change in Lipid profile [28 days]

  7. Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age) [28 days]

  8. Number of adverse events [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Frankfurt, Medizinische Klinik I, Gastroenterologie/Hepatologie; Frankfurt, Germany Frankfurt Germany

Sponsors and Collaborators

  • Amazentis SA
  • Goethe University

Investigators

  • Principal Investigator: Dr. Dominic Denk, MD, Universitätsklinikum Frankfurt Medizinische Klinik I

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amazentis SA
ClinicalTrials.gov Identifier:
NCT05735886
Other Study ID Numbers:
  • 22.03.AMZ
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 21, 2023