Health TrialsbyHealthPanel

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

ConditionAging, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorYOXLO B.V.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Youniqor SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events

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

Time frame
8 weeks
2

Tolerability will be assessed

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

Time frame
8 weeks

Secondary outcomes

1

Change in blood pressure (systolic and diastolic)

Change from baseline of systolic and diastolic blood pressure

Time frame
8 weeks
2

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).

Time frame
8 weeks
3

Change in liver function

Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline

Time frame
8 weeks
4

Change in QTc interval

Change in QTc interval derived from 12-lead resting ECG compared to baseline

Time frame
8 weeks

Other outcomes

1

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

Time frame
8 weeks
2

Change in Cognitive Performance (CTT)

Assessment of cognitive performance using the Color Trails Test (CTT) as compared to baseline

Time frame
8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

YOXLO B.V.

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Collaborator

Source ClinicalTrials.gov
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