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

NCT07442097 | Recruiting

• 1 other identifier: SAFE-AGE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Aging, Healthy

Keywords

Aging; Healthy Volunteers; nutritional supplement; safety study

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Assessment of the incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.

  8 weeks

• Tolerability will be assessed

  Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events

  8 weeks

Secondary Outcomes (6)

• Change in blood pressure (systolic and diastolic)

  8 weeks

• Clinically significant ECG abnormalities

  8 weeks

• Change in liver function

  8 weeks

• Change in QTc interval

  8 weeks

• Change in renal function

  8 weeks

Other Outcomes (2)

• Change in Six-Minute Walk Test (6MWT)

  8 weeks

• Change in Cognitive Performance (CTT)

  8 weeks

Study Arms (1)

Youniqor Supplement

EXPERIMENTAL

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.

Dietary Supplement: Youniqor

Interventions

Youniqor DIETARY_SUPPLEMENT

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

Youniqor Supplement

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YOXLO B.V.: lead
• Vedic Lifesciences Pvt. Ltd.: collaborator

Study Sites (1)

Vedic Lifesciences Pvt. Ltd.

Pune, Maharashtra, 411045, India

RECRUITING

Central Study Contacts

Stef F Verlinden, MD

CONTACT

+31618516018; stef@yoxlo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 2, 2026
• Study Start: February 12, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

IN (1)