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

Last updated: January 21, 2025
Sponsor: IBSA Farmaceutici Italia Srl
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Treatment

Salvia haenkei 175mg

Salvia haenkei 350mg

Clinical Study ID

NCT05936346
IB-IT-SAL-22
  • Ages 55-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 theInvestigator makes the subject unsuitable for the study

  • Planned or anticipated major surgical procedure during the subject's participationin 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 sportsdrink, of any kind, liable or presented as liable to enhance physical performanceswithin one month prior to the start and during the study

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Salvia haenkei 175mg
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Ospedale Regionale di Lugano

    Lugano,
    Switzerland

    Active - Recruiting

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