Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
Informed consent as documented by signature
Male or female
Age 55-65 years, inclusive
In good general health as evidenced by medical history and current health status
Body Mass Index < 18.5 or ≥ 30
Difficulty in swallowing (dysphagia)
Known allergy or sensitivity to any ingredient of the study intervention
Any medical condition or clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis) at screening which in the judgment of the Investigator makes the subject unsuitable for the study
Parallel
Salvia haenkei 175mg
Dietary supplementThe product appears as a soft gel containing the dry extract of Salvia haenkei
Salvia haenkei 350mg
Dietary supplementThe product appears as a soft gel containing the dry extract of Salvia haenkei
Occurrence of adverse events
Number of adverse events, serious adverse events, clinically significant changes in clinical laboratory assessments (hematology, chemistry, urinalysis) and clinically significant changes in vital signs or other clinical assessments will be evaluated.
Tolerability assessment by evaluation of the number of subjects who will not withdraw prematurely from the study
Tolerability is defined as the number of subjects who will not withdraw prematurely from the study due to the occurrence of any AEs or SAEs.
Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer
Subjects will be asked to squeeze rubber balls (available in three sizes) three times for each side using the dominant hand. The best result of the 3 attempts will be taken into consideration.
Change from baseline of muscle strength assessed by repeated chair stand test
Repeated chair stand test is a timed test requiring subjects to rise from a chair without using their arms and return to the seated position, consecutively, for five times. This test has been shown to be able to provide a reliable and valid indication of lower body strength. The cut-off is \> 15 seconds for five rises.
Change from baseline of physical performance assessed by gait speed test
Gait speed test is used to assess walking speed in meters per second over a 4-metre distance at a comfortable pace. Subjects with a gait speed \<0.8 m/s are described as having a poor physical performance.
Change from baseline of physical performance assessed by six minute walking test
The six minute walking test will assess functional exercise capacity. The test will measure the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
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