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

NCT ID: NCT05936346

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2025-04-30

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lower dose (175mg)

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

Group Type: EXPERIMENTAL

Salvia haenkei 175mg

Intervention Type: DIETARY_SUPPLEMENT

The product appears as a soft gel containing the dry extract of Salvia haenkei

Higher dose (350mg)

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

Group Type: EXPERIMENTAL

Salvia haenkei 350mg

Intervention Type: DIETARY_SUPPLEMENT

The product appears as a soft gel containing the dry extract of Salvia haenkei

Interventions

Salvia haenkei 175mg

The product appears as a soft gel containing the dry extract of Salvia haenkei

Intervention Type: DIETARY_SUPPLEMENT

Salvia haenkei 350mg

The product appears as a soft gel containing the dry extract of Salvia haenkei

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IBSA Farmaceutici Italia Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberta Noseda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)

Locations

Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Tatiana Terrot

Role: CONTACT

Tatiana.Terrot@eoc.ch

+41 91 811 7962

Facility Contacts

Tatiana Terrot

Role: primary

Other Identifiers

IB-IT-SAL-22

Identifier Type: -

Identifier Source: org_study_id