Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Youniqor.
- Who it may be relevant to
- Registry conditions: Aging, Healthy. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
Overview
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 supplement Youniqor
Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.
Primary outcome measures
- Incidence of Adverse Events [Time frame: 8 weeks]
- Tolerability will be assessed [Time frame: 8 weeks]
Secondary outcome measures (6)
- Change in blood pressure (systolic and diastolic) [Time frame: 8 weeks]
- Clinically significant ECG abnormalities [Time frame: 8 weeks]
- Change in liver function [Time frame: 8 weeks]
- Change in QTc interval [Time frame: 8 weeks]
- Change in renal function [Time frame: 8 weeks]
- Change in complete blood count (CBC) [Time frame: 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
India · 1 center
- Vedic Lifesciences Pvt. Ltd. — Pune
Identifiers
NCT: NCT07442097 · SAFE-AGE