Aging, Healthy
Conditions
Keywords
Aging, Healthy Volunteers, nutritional supplement, safety study
Brief 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
Detailed description
This is an open-label, single-arm interventional study designed to assess the safety and tolerability of the nutritional supplement Youniqor in healthy older adults. The study will enroll men and women aged 60 to 80 years who meet predefined eligibility criteria and provide written informed consent. Participants will receive daily oral supplementation with Youniqor for a period of 8 weeks. Safety will be monitored throughout the study through the assessment of adverse events, vital signs, clinical laboratory parameters, and electrocardiograms at predefined time points. The study is conducted at clinical research sites in India under the oversight of an independent ethics committee and in accordance with applicable regulatory and ethical guidelines. The results of this study are intended to support the characterization of the safety profile of Youniqor in healthy older adults.
Interventions
DIETARY_SUPPLEMENTYouniqor
Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.
Sponsors
YOXLO B.V.
Vedic Lifesciences Pvt. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 8 weeks | Assessment of the incidence, nature, and severity of adverse events and serious adverse events occurring during the study period. |
| Tolerability will be assessed | 8 weeks | Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure (systolic and diastolic) | 8 weeks | Change from baseline of systolic and diastolic blood pressure |
| Clinically significant ECG abnormalities | 8 weeks | Number of participants with clinically significant abnormalities on 12-lead resting ECG, as determined by Investigator/medical monitor review (including heart rate/rhythm and interval abnormalities). |
| Change in liver function | 8 weeks | Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline |
| Change in QTc interval | 8 weeks | Change in QTc interval derived from 12-lead resting ECG compared to baseline |
| Change in renal function | 8 weeks | Change of renal function as measured by serum albumin in g/dL compared with the baseline |
| Change in complete blood count (CBC) | 8 weeks | Change in complete blood count as compared to baseline |
Countries
India
Contacts
CONTACTStef F Verlinden, MD
Outcome results
None listed