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

NCT05936346 | Recruiting

• 1 other identifier: IB-IT-SAL-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events

  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.

  From Day 0 to Day 90

• Tolerability assessment by evaluation of the number of subjects who will not withdraw prematurely from the study

  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.

  From Day 0 to Day 90

Secondary Outcomes (12)

• Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer

  Day 0, Day 90

• Change from baseline of muscle strength assessed by repeated chair stand test

  Day 0, 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 BMI calculation (weight/height^2)

  Day 0, Day 90

Study Arms (2)

Lower dose (175mg)

EXPERIMENTAL

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

Dietary Supplement: Salvia haenkei 175mg

Higher dose (350mg)

EXPERIMENTAL

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

Dietary Supplement: Salvia haenkei 350mg

Interventions

Salvia haenkei 175mg DIETARY_SUPPLEMENT

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

Lower dose (175mg)

Salvia haenkei 350mg DIETARY_SUPPLEMENT

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

Higher dose (350mg)

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead

Study Sites (1)

Ospedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

Study Officials

• Roberta Noseda, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Terrot

CONTACT

+41 91 811 7962; Tatiana.Terrot@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open label, Parallel-arm, Two-dose Study

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 7, 2023
• Study Start: July 17, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

CH (1)