Menu
Recruiting NCT05936346

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

No phase Interventional Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Salvia haenkei 175mg, Salvia haenkei 350mg.
Who it may be relevant to
Registry conditions: Aging. Basic parameters: 55 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Occurrence of adverse events [Time frame: From Day 0 to Day 90]
  • Tolerability assessment by evaluation of the number of subjects who will not withdraw prematurely from the study [Time frame: From Day 0 to Day 90]
Secondary outcome measures (12)
  • Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer [Time frame: Day 0, Day 90]
  • Change from baseline of muscle strength assessed by repeated chair stand test [Time frame: Day 0, Day 90]
  • Change from baseline of physical performance assessed by gait speed test [Time frame: Day 0, Day 90]
  • Change from baseline of physical performance assessed by six minute walking test [Time frame: Day 0, Day 90]
  • Change from baseline of muscle mass assessed by BMI calculation (weight/height^2) [Time frame: Day 0, Day 90]
  • Change from baseline of muscle mass assessed by calf circumference measurement (cm) [Time frame: Day 0, Day 90]
  • Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm) [Time frame: Day 0, Day 90]
  • Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire [Time frame: Day 0, Day 90]
  • Change from baseline of muscle echogenicity assessed by muscle ultrasound [Time frame: Day 0, Day 90]
  • Change from baseline of muscle thickness assessed by muscle ultrasound [Time frame: Day 0, Day 90]
  • Change from baseline of DNA Methylation [Time frame: Day 0, Day 90]
  • Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation [Time frame: Day 0, Day 45, Day 90]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Ospedale Regionale di Lugano — Lugano

Identifiers

NCT: NCT05936346 · IB-IT-SAL-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗