NCT07442097 Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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

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