Trials / Recruiting
RecruitingNCT07442097
Safe-Age Study: A Safety and Tolerability Study of a Nutritional Supplement in Healthy Older Adults
An Open-Label, Single-Arm Study to Assess the Safety of Youniqor Consumption in Healthy Adults
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- YOXLO B.V. · Industry
- Sex
- All
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-12
- Primary completion
- 2026-07-10
- Completion
- 2026-07-31
- First posted
- 2026-03-02
- Last updated
- 2026-03-02
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT07442097. Inclusion in this directory is not an endorsement.