An Open-label, Single-arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
Aging is associated with a gradual decline in physiological function, accompanied by changes in cellular stress responses, redox balance, and mitochondrial function, which may contribute to increased vulnerability to chronic disease and functional impairment.
Youniqor is a proprietary nutraceutical formulation containing N-acetyl-L-cysteine (NAC) and glycine. This open-label, single-arm Phase 1 study evaluates the safety and tolerability of daily Youniqor consumption for 8 weeks in healthy adults aged 60–80 years. Safety will be assessed through adverse event monitoring, vital signs, clinical laboratory testing (hematology, renal and liver function, electrolytes, fasting glucose, lipid profile), urinalysis, and 12-lead ECG. Exploratory assessments of muscle, cognitive, and immune function will be performed to inform the design of future XPRIZE Healthspan-aligned studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals willing to give written informed consent to participate in the study.
- •Healthy men and women aged 60 to 80 years (both values included).
- •Individuals with Body Mass Index (BMI) 22.5 to 29.9 kg per meter square (both values included).
- •Individuals with hsCRP levels 0.7 to 5.0 mg per Liter (both values included).
- •Individuals willing to avoid specific training and or practice on the muscle and or cognition endpoints during the study.
- •Compliance with the requirements of the entire protocol.
- •Individuals willing to follow all the study procedures and follow-up visits.
排除标准
- •Individuals with chronic/inflammatory or cardiometabolic disease requiring daily medication.
- •Presence of uncontrolled diabetes mellitus (Indicated by fasting blood glucose greater than or equal to 126 mg/dL).
- •3.Individuals with hypertension.
- •Individuals with eGFR less than 60 mL/min/1.73 m².
- •Individuals with AST/ALT greater than 2× Upper Limit of Normal (ULN).
- •Individuals with WBC count below 3500/mm
- •Individuals with any ongoing or history of acute infection within past 2 weeks.
- •Individuals with recent vaccination within past 4 weeks.
- •Individuals who have targeted practice on study endpoints.
- •Diagnosed with neurodegenerative, neurological or other major psychiatric disorders.
- •Any other conditions which may, in the Investigator’s opinion, be accompanied by anemia, chronic diseases or anticoagulation therapy.
- •Individuals who are on systemic corticosteroids, immunosuppressants or chronic pain medications.
- •Participation in other clinical trials in last 90 days prior to screening.
- •Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigator’s clinical judgment.
- •Current smokers.
研究者
Dr Ishan Mishra
Vedic Lifesciences Pvt Ltd