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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Occurrence of adverse events
时间窗: 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
时间窗: 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.
次要结局
- 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)