Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults

Официальное название

An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Youniqor
  Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.

Первичные конечные точки

• Incidence of Adverse Events [Срок оценки: 8 weeks]
• Tolerability will be assessed [Срок оценки: 8 weeks]

Вторичные конечные точки (6)

• Change in blood pressure (systolic and diastolic) [Срок оценки: 8 weeks]
• Clinically significant ECG abnormalities [Срок оценки: 8 weeks]
• Change in liver function [Срок оценки: 8 weeks]
• Change in QTc interval [Срок оценки: 8 weeks]
• Change in renal function [Срок оценки: 8 weeks]
• Change in complete blood count (CBC) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Индия · 1 центр

• Vedic Lifesciences Pvt. Ltd. — Pune

Идентификаторы

NCT: NCT07442097 · SAFE-AGE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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