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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose (175mg) | Experimental | The study intervention consists of a single daily oral intake 175 mg of Salvia haenkei as soft capsule over a period of 3 months. |
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| Higher dose (350mg) | Experimental | The study intervention consists of a single daily oral intake 350 mg of Salvia haenkei as soft capsule over a period of 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salvia haenkei 175mg | Dietary Supplement | The product appears as a soft gel containing the dry extract of Salvia haenkei |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Day 0 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Day 90 |
| Change from baseline of muscle strength assessed by repeated chair stand test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Terrot | Contact | +41 91 811 7962 | Tatiana.Terrot@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Roberta Noseda, MD, PhD | Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale di Lugano | Recruiting | Lugano | Switzerland |
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Randomized, Open label, Parallel-arm, Two-dose Study
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| Salvia haenkei 350mg | Dietary Supplement | The product appears as a soft gel containing the dry extract of Salvia haenkei |
|
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. |
| 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. | Day 0, Day 90 |
| 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. | 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) | 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) | 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). | 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. | Day 0, Day 90 |
| Change from baseline of muscle echogenicity assessed by muscle ultrasound | Muscle echogenicity will be measured using a semi-quantitative scale | Day 0, Day 90 |
| Change from baseline of muscle thickness assessed by muscle ultrasound | Muscle thickness (mm) will be measured by muscle ultrasound | 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) | 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) | Day 0, Day 45, Day 90 |