Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
ConditionAging, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorYOXLO B.V.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Youniqor
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
YOXLO B.V.
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborator
Source ClinicalTrials.gov