Actively Recruiting
Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
Led by YOXLO B.V. · Updated on 2026-03-02
16
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
Y
YOXLO B.V.
Lead Sponsor
V
Vedic Lifesciences Pvt. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 80 years
- Body mass index (BMI) between 22.5 and 29.9 kg/m8
- High-sensitivity C-reactive protein (hsCRP) levels between 0.7 and 5.0 mg/L
- Willingness to provide written informed consent
- Willingness to follow all study procedures and attend follow-up visits
- Willingness to avoid major lifestyle changes such as new physical or cognitive training during the study
You will not qualify if you...
- Presence of chronic, inflammatory, or cardiometabolic disease requiring daily medication
- Uncontrolled diabetes mellitus (fasting blood glucose 3126 mg/dL)
- Hypertension
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m8
- Elevated liver enzymes (AST or ALT more than twice the upper limit of normal)
- Low white blood cell count (less than 3500/mm3)
- Recent acute infection within 2 weeks before screening
- Vaccination within 4 weeks prior to screening
- Allergy or intolerance to N-acetyl-L-cysteine (NAC) or glycine
- Participation in another clinical trial within 90 days prior to screening
- Recent or current use of systemic corticosteroids, immunosuppressants, or chronic pain medications
- Neurodegenerative, neurological, or major psychiatric disorders
- History of alcohol or drug abuse
- Current smokers
- Any condition that may interfere with study participation or safety according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vedic Lifesciences Pvt. Ltd.
Pune, Maharashtra, India, 411045
Actively Recruiting
Research Team
S
Stef F Verlinden, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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