Youniqor safety and tolerability in healthy older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm trial enrolls healthy men and women aged 60–80 who meet specific BMI and hsCRP ranges to receive daily oral Youniqor for 8 weeks. Safety monitoring includes recording adverse events and scheduled assessments of vital signs, clinical laboratory tests, urine analysis, and electrocardiograms. The trial excludes people with chronic inflammatory or cardiometabolic conditions, uncontrolled diabetes, hypertension, significant kidney or liver impairment, recent infection, or recent vaccination. Conducted at clinical research sites in Pune, India, the study uses predefined timepoints to characterize any clinically relevant changes during the supplementation period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vedic Lifesciences Pvt. Ltd.
  Pune, Maharashtra, India Recruiting

Study contacts

• Study coordinator: Stef F Verlinden, MD
• Email: stef@yoxlo.com
• Phone: +31618516018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.