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

IBSA

Status: Enrolling

Conditions: Aging

Treatments: Dietary Supplement: Salvia haenkei 175mg; Dietary Supplement: Salvia haenkei 350mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05936346

IB-IT-SAL-22

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Lower dose (175mg)

Experimental group

Description:

The study intervention consists of a single daily oral intake 175 mg of Salvia haenkei as soft capsule over a period of 3 months.

Treatment:

Dietary Supplement: Salvia haenkei 175mg

Higher dose (350mg)

Experimental group

Description:

The study intervention consists of a single daily oral intake 350 mg of Salvia haenkei as soft capsule over a period of 3 months.

Treatment:

Dietary Supplement: Salvia haenkei 350mg