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Urolithin A Supplementation to Boost Immune Health

A

Amazentis

Status

Completed

Conditions

Aging

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05735886
22.03.AMZ

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Softgel containing placebo
Urolithin A (Mitopure)
Active Comparator group
Treatment:
Dietary Supplement: Softgel containing 250mg of Urolithin A (Mitopure)

Trial contacts and locations

1

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Central trial contact

Dr. Anurag Singh, MD, PhD

Data sourced from clinicaltrials.gov

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