Evalution of the safety and tolerability of the oral administration of Salvia haenkei in
a healthy population.

Evaluation of Safety and Tolerability of Salvia Haenkei Extract as a Dietary Supplement Ingredient

Aging

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.

Salvia haenkei 175mg

Salvia haenkei 350mg

Evaluation of Safety and Tolerability of Salvia Haenkei Extract as a Dietary Supplement Ingredient in a Healthy Population: A Randomized, Open Label, Parallel-arm, Two-dose Study

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 is defined as the number of subjects who will not withdraw prematurely from
the study due to the occurrence of any AEs or SAEs.

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.

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.

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.

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.

Muscle mass will be measured BMI calculation (weight/height^2)

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)

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).

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.

Muscle echogenicity will be measured using a semi-quantitative scale

Muscle thickness (mm) will be measured by muscle ultrasound

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)

Blood biomarkers indicative of aging, metabolism and inflammation including cytokines and
other relevant biomarkers will be quantified by ELISA (translational endpoint)

The study intervention consists of a single daily oral intake 175 mg of Salvia haenkei as
soft capsule over a period of 3 months.

The study intervention consists of a single daily oral intake 350 mg of Salvia haenkei as
soft capsule over a period of 3 months.

Evaluation of Safety and Tolerability of Salvia Haenkei Extract as a Dietary Supplement Ingredient

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status