Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
The aim of the study is to assess the safety and tolerability of the oral administration of Salvia haenkei in a healthy population. Furthermore, Salvia haenkei has been identified as a potential anti-senescence agent and may counteract aging and aging-associated disorders. In this scenario, the current study aims also at exploring the effects of this supplementation on muscular and other organ functions (kidney, liver, heart, etc.) and on systemic inflammation and metabolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The product appears as a soft gel containing the dry extract of Salvia haenkei
The product appears as a soft gel containing the dry extract of Salvia haenkei
Ospedale Regionale di Lugano
Lugano, Switzerland
RECRUITINGOccurrence 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.
Time frame: From Day 0 to Day 90
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.
Time frame: From Day 0 to Day 90
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.
Time frame: Day 0, Day 90
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.
Time frame: Day 0, Day 90
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.
Time frame: Day 0, Day 90
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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.
Time frame: Day 0, Day 90
Change from baseline of muscle mass assessed by BMI calculation (weight/height^2)
Muscle mass will be measured BMI calculation (weight/height\^2)
Time frame: Day 0, Day 90
Change from baseline of muscle mass assessed by calf circumference measurement (cm)
Muscle mass will be measured using calf circumference (maximum circumference of calf of lower non-dominant leg bent at 90 degrees, cut-off \<31 cm)
Time frame: Day 0, Day 90
Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm)
Muscle mass will be measured using mid-upper arm circumference (circumference at halfway point between the olecranon process and acromion while arm is bent at 90 degrees, cut-off \<22.5 cm).
Time frame: Day 0, Day 90
Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire
The subject will be asked 5 questions addressing strength, assistance in walking, rising from a chair, stair climbing and falls. Each component is scored from 0 to 2 points, giving a global score of the SARC-F between 0 and 10 points. A score ≥ 4 points is reported to be predictive of sarcopenia and poor outcomes.
Time frame: Day 0, Day 90
Change from baseline of muscle echogenicity assessed by muscle ultrasound
Muscle echogenicity will be measured using a semi-quantitative scale
Time frame: Day 0, Day 90
Change from baseline of muscle thickness assessed by muscle ultrasound
Muscle thickness (mm) will be measured by muscle ultrasound
Time frame: Day 0, Day 90
Change from baseline of DNA Methylation
Assessment of methylation status in 353 CpG sites associated with aging from DNA in whole blood. The analysis of DNA Methylation will be done only for the 25 subjects enrolled to the high dosage arm \[350 mg\]) (translational endpoint)
Time frame: Day 0, Day 90
Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation
Blood biomarkers indicative of aging, metabolism and inflammation including cytokines and other relevant biomarkers will be quantified by ELISA (translational endpoint)
Time frame: Day 0, Day 45, Day 90