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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Salvia haenkei 175mg
  The product appears as a soft gel containing the dry extract of Salvia haenkei
• Пищевая добавка Salvia haenkei 350mg
  The product appears as a soft gel containing the dry extract of Salvia haenkei

Первичные конечные точки

• Occurrence of adverse events [Срок оценки: From Day 0 to Day 90]
• Tolerability assessment by evaluation of the number of subjects who will not withdraw prematurely from the study [Срок оценки: From Day 0 to Day 90]

Вторичные конечные точки (12)

• Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle strength assessed by repeated chair stand test [Срок оценки: Day 0, Day 90]
• Change from baseline of physical performance assessed by gait speed test [Срок оценки: Day 0, Day 90]
• Change from baseline of physical performance assessed by six minute walking test [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle mass assessed by BMI calculation (weight/height^2) [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle mass assessed by calf circumference measurement (cm) [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm) [Срок оценки: Day 0, Day 90]
• Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle echogenicity assessed by muscle ultrasound [Срок оценки: Day 0, Day 90]
• Change from baseline of muscle thickness assessed by muscle ultrasound [Срок оценки: Day 0, Day 90]
• Change from baseline of DNA Methylation [Срок оценки: Day 0, Day 90]
• Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation [Срок оценки: Day 0, Day 45, Day 90]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Ospedale Regionale di Lugano — Lugano

Идентификаторы

NCT: NCT05936346 · IB-IT-SAL-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗