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

YOXLO B.V.

Status: Enrolling

Conditions: Aging, Healthy

Treatments: Dietary Supplement: Youniqor

Study type: Interventional

Funder types: Industry

Identifiers

NCT07442097

SAFE-AGE

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Youniqor Supplement

Experimental group

Description:

Participants in this arm will receive the nutritional supplement Youniqor, administered orally twice daily for a period of 8 weeks. All participants will follow the same intervention and undergo scheduled safety assessments throughout the study.

Treatment:

Dietary Supplement: Youniqor