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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Salvia haenkei 175mg; Dietary supplement: Salvia haenkei 350mg

Detailed Description

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
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Terrot; Phone Number: +41 91 811 7962; Email: Tatiana.Terrot@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland
    • Recruiting
    • Ospedale Regionale di Lugano
    • Contact: Tatiana Terrot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• Willingness to maintain dietary and sports habits as of baseline
• Willingness and ability to comply with the requirements of the study

Exclusion Criteria:

• 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
• Planned or anticipated major surgical procedure during the subject's participation in this study
• Inability or contraindications to undergo the study intervention
• Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
• Use of any new vitamins, herbal or dietary supplements, functional foods and sports drink, of any kind, liable or presented as liable to enhance physical performances within one month prior to the start and during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower dose (175mg); The study intervention consists of a single daily oral intake 175 mg of Salvia haenkei as soft capsule over a period of 3 months.	Dietary supplement: Salvia haenkei 175mg; The product appears as a soft gel containing the dry extract of Salvia haenkei
Experimental: Higher dose (350mg); The study intervention consists of a single daily oral intake 350 mg of Salvia haenkei as soft capsule over a period of 3 months.	Dietary supplement: Salvia haenkei 350mg; The product appears as a soft gel containing the dry extract of Salvia haenkei

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: IBSA Farmaceutici Italia Srl
• Investigators: Principal Investigator: Roberta Noseda, MD, PhD, Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IB-IT-SAL-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No