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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IBSA Farmaceutici Italia Srl
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Occurrence of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Occurrence of adverse events
Time Frame: From Day 0 to Day 90
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 assessment by evaluation of the number of subjects who will not withdraw prematurely from the study
Time Frame: From Day 0 to Day 90
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.
Secondary Outcomes
- Change from baseline of muscle mass assessed by BMI calculation (weight/height^2)(Day 0, Day 90)
- Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm)(Day 0, Day 90)
- Change from baseline of DNA Methylation(Day 0, Day 90)
- Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer(Day 0, Day 90)
- Change from baseline of muscle echogenicity assessed by muscle ultrasound(Day 0, Day 90)
- Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation(Day 0, Day 45, Day 90)
- Change from baseline of physical performance assessed by gait speed test(Day 0, Day 90)
- Change from baseline of physical performance assessed by six minute walking test(Day 0, Day 90)
- Change from baseline of muscle mass assessed by calf circumference measurement (cm)(Day 0, Day 90)
- Change from baseline of muscle strength assessed by repeated chair stand test(Day 0, Day 90)
- Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire(Day 0, Day 90)
- Change from baseline of muscle thickness assessed by muscle ultrasound(Day 0, Day 90)