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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aging, Healthy
• Intervention / Treatment: Dietary supplement: Youniqor

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stef F Verlinden, MD; Phone Number: +31618516018; Email: stef@yoxlo.com

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411045
      • Recruiting
      • Vedic Lifesciences Pvt. Ltd.
      • Contact: Kishori Pasthe, Dr; Phone Number: ‭+91 82917 57065‬; Email: clinicaltrials@vediclifesciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Youniqor Supplement; 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; Youniqor is an orally administered nutritional supplement. Participants will take the supplement twice daily for 8 weeks as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure (systolic and diastolic)	Change from baseline of systolic and diastolic blood pressure	8 weeks
Clinically significant ECG abnormalities	Number of participants with clinically significant abnormalities on 12-lead resting ECG, as determined by Investigator/medical monitor review (including heart rate/rhythm and interval abnormalities).	8 weeks
Change in liver function	Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline	8 weeks
Change in QTc interval	Change in QTc interval derived from 12-lead resting ECG compared to baseline	8 weeks
Change in renal function	Change of renal function as measured by serum albumin in g/dL compared with the baseline	8 weeks
Change in complete blood count (CBC)	Change in complete blood count as compared to baseline	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Six-Minute Walk Test (6MWT)	Assessment of functional exercise capacity using the Six-Minute Walk Test, measured as the distance walked in six minutes as compared to baseline	8 weeks
Change in Cognitive Performance (CTT)	Assessment of cognitive performance using the Color Trails Test (CTT) as compared to baseline	8 weeks

Collaborators and Investigators

• Sponsor: YOXLO B.V.
• Collaborators: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Aging; nutritional supplement; safety study
• Other Study ID Numbers: SAFE-AGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No