Youniqor safety and tolerability in healthy older adults

An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults

This will test whether taking the nutritional supplement Youniqor daily for 8 weeks is safe and well tolerated by healthy adults aged 60 to 80.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Yoxlo B.v. (Industry-sponsored)
• Locations: 1 site (Pune, Maharashtra)
• Trial ID: NCT07442097 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 60–80 with a BMI of 22.5–29.9 kg/m², hsCRP between 0.7 and 5.0 mg/L, and no chronic inflammatory or cardiometabolic conditions requiring daily medication.

Not a fit: People with chronic inflammatory or cardiometabolic disease, uncontrolled diabetes, hypertension, impaired kidney or liver function, recent infection or vaccination, or known allergies to supplement ingredients are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If results show good tolerability and no concerning safety signals, this could support further testing or wider use of Youniqor in older adults.

How similar studies have performed: Short-term safety and tolerability studies of nutritional supplements in older adults are common and generally report acceptable tolerability, but Youniqor itself appears to have limited published human data.

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 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 this trial is running

Pune, Maharashtra

• Vedic Lifesciences Pvt. Ltd. — Pune, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: Stef F Verlinden, MD

Conditions Aging, Healthy; Aging; Healthy Volunteers; nutritional supplement; safety study