Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
YOXLO B.V.
16 participants
Feb 12, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The main questions it aims to answer are: Is Youniqor safe and well tolerated when taken daily by healthy adults aged 60 to 80 years? Are there any adverse events or clinically relevant changes in vital signs or laboratory parameters during the study period? Participants will: Take Youniqor daily for 8 weeks Attend scheduled study visits for safety assessments, including vital signs, blood and urine tests, and electrocardiograms Report any adverse events during the study period
Eligibility
Inclusion Criteria5
- Body mass index (BMI) between 22.5 and 29.9 kg/m², inclusive.
- High-sensitivity C-reactive protein (hsCRP) levels between 0.7 and 5.0 mg/L, inclusive.
- Willingness to provide written informed consent.
- Willingness to comply with all study procedures and follow-up visits.
- Willingness to avoid major lifestyle changes, including new structured physical training or cognitive training targeting study endpoints, during the study period.
Exclusion Criteria15
- Presence of chronic, inflammatory, or cardiometabolic disease requiring daily medication.
- Uncontrolled diabetes mellitus (fasting blood glucose ≥126 mg/dL).
- Hypertension.
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× the upper limit of normal.
- White blood cell count <3500/mm³.
- Ongoing or recent acute infection within 2 weeks prior to screening.
- Vaccination within 4 weeks prior to screening.
- Known allergy or intolerance to N-acetyl-L-cysteine (NAC) or glycine.
- Participation in another clinical trial within 90 days prior to screening.
- Current or recent use of systemic corticosteroids, immunosuppressants, or chronic pain medications.
- neurodegenerative, neurological, or major psychiatric disorders.
- History of alcohol or drug abuse based on medical history, physical examination, or investigator judgment.
- Current smokers.
- Any other condition which, in the opinion of the investigator, may interfere with study participation or safety.
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Interventions
Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07442097