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| Name | Class |
|---|---|
| Vedic Lifesciences Pvt. Ltd. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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). |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stef F Verlinden, MD | Contact | +31618516018 | stef@yoxlo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vedic Lifesciences Pvt. Ltd. | Recruiting | Pune | Maharashtra | 411045 | India |
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| 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 |
Assessment of cognitive performance using the Color Trails Test (CTT) as compared to baseline
| 8 weeks |