Clinical trial NCT05936346: Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Open label, Parallel-arm, Two-dose Study
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: From Day 0 to Day 90
measure: Tolerability assessment by evaluation of the number of subjects who will not withdraw prematurely from the study
timeFrame: From Day 0 to Day 90
Secondary outcomes:
measure: Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle strength assessed by repeated chair stand test
timeFrame: Day 0, Day 90
measure: Change from baseline of physical performance assessed by gait speed test
timeFrame: Day 0, Day 90
measure: Change from baseline of physical performance assessed by six minute walking test
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle mass assessed by BMI calculation (weight/height^2)
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle mass assessed by calf circumference measurement (cm)
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm)
timeFrame: Day 0, Day 90
measure: Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle echogenicity assessed by muscle ultrasound
timeFrame: Day 0, Day 90
measure: Change from baseline of muscle thickness assessed by muscle ultrasound
timeFrame: Day 0, Day 90
measure: Change from baseline of DNA Methylation
timeFrame: Day 0, Day 90
measure: Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation
timeFrame: Day 0, Day 45, Day 90
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
Study officials:
affiliation: Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)
name: Roberta Noseda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: