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Clinical Trials in India / NCT07442097
Recruiting Not applicable

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

NCT07442097 · tracked via the Priya Life Science India tracker
Sponsor
YOXLO B.V.
Phase
Not applicable
Started
2026-02-12
Last updated
2026-03-02

Condition(s) studied

Aging, Healthy

Investigational drug(s) / intervention(s)

Youniqor

Youniqor: Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.

Study 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

Sex
ALL
Min age
60 Years
Max age
80 Years
Healthy volunteers
Accepted
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 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Vedic Lifesciences Pvt. Ltd. Pune Maharashtra Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07442097 on ClinicalTrials.gov ↗ ← All trials in India