AgingNCT05936346
Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient
A study testing Salvia haenkei 175mg and Salvia haenkei 350mg in people with Aging, run by IBSA Farmaceutici Italia Srl at 1 site in Switzerland.
Trial summary
Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Salvia haenkei 175mg and Salvia haenkei 350mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jul 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale di Lugano
Lugano
Tatiana Terrot
About this study
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
Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
Read the 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
- Being tested
- Salvia haenkei 175mg, Salvia haenkei 350mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvia haenkei 175mgDietary supplement
The product appears as a soft gel containing the dry extract of Salvia haenkei
Salvia haenkei 350mgDietary supplement
The product appears as a soft gel containing the dry extract of Salvia haenkei
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Salvia haenkei 350mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Day 0 to Day 90
Secondary outcomes (12)
Change from baseline of muscle strength assessed by grip test using the pneumatic dynamometer
Subjects will be asked to squeeze rubber balls (available in three sizes) three times for each side using the dominant hand. The best result of the 3 attempts will be taken into consideration.
Measured: Day 0, Day 90
Change from baseline of muscle strength assessed by repeated chair stand test
Repeated chair stand test is a timed test requiring subjects to rise from a chair without using their arms and return to the seated position, consecutively, for five times. This test has been shown to be able to provide a reliable and valid indication of lower body strength. The cut-off is > 15 seconds for five rises.
Measured: Day 0, Day 90
Change from baseline of physical performance assessed by gait speed test
Gait speed test is used to assess walking speed in meters per second over a 4-metre distance at a comfortable pace. Subjects with a gait speed <0.8 m/s are described as having a poor physical performance.
Measured: Day 0, Day 90
Change from baseline of physical performance assessed by six minute walking test
The six minute walking test will assess functional exercise capacity. The test will measure the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
Measured: Day 0, Day 90
Change from baseline of muscle mass assessed by BMI calculation (weight/height^2)
Muscle mass will be measured BMI calculation (weight/height^2)
Measured: Day 0, Day 90
Change from baseline of muscle mass assessed by calf circumference measurement (cm)
Muscle mass will be measured using calf circumference (maximum circumference of calf of lower non-dominant leg bent at 90 degrees, cut-off <31 cm)
Measured: Day 0, Day 90
Change from baseline of muscle mass assessed by mid-upper arm circumference measurement (cm)
Muscle mass will be measured using mid-upper arm circumference (circumference at halfway point between the olecranon process and acromion while arm is bent at 90 degrees, cut-off <22.5 cm).
Measured: Day 0, Day 90
Change from baseline of the risk of sarcopenia assessed by SARC-F questionnaire
The subject will be asked 5 questions addressing strength, assistance in walking, rising from a chair, stair climbing and falls. Each component is scored from 0 to 2 points, giving a global score of the SARC-F between 0 and 10 points. A score ≥ 4 points is reported to be predictive of sarcopenia and poor outcomes.
Measured: Day 0, Day 90
Change from baseline of muscle echogenicity assessed by muscle ultrasound
Muscle echogenicity will be measured using a semi-quantitative scale
Measured: Day 0, Day 90
Change from baseline of muscle thickness assessed by muscle ultrasound
Muscle thickness (mm) will be measured by muscle ultrasound
Measured: Day 0, Day 90
Change from baseline of DNA Methylation
Assessment of methylation status in 353 CpG sites associated with aging from DNA in whole blood. The analysis of DNA Methylation will be done only for the 25 subjects enrolled to the high dosage arm [350 mg]) (translational endpoint)
Measured: Day 0, Day 90
Change from baseline of the amount of blood biomarkers indicative of aging, metabolism and inflammation
Blood biomarkers indicative of aging, metabolism and inflammation including cytokines and other relevant biomarkers will be quantified by ELISA (translational endpoint)
Measured: Day 0, Day 45, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start17 Jul 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open label, Parallel-arm, Two-dose Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberta Noseda, MD, PhD, Principal investigator, Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936346
- Sponsor's protocol ID
- IB-IT-SAL-22
- Status last verified
- Jan 2025
- First submitted
- 22 Jun 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05936346
- Acronym / sponsor ID
- IB-IT-SAL-22
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open label, Parallel-arm, Two-dose Study
| Arm | Type | Receives |
|---|---|---|
| Lower dose (175mg) | Experimental | Dietary Supplement: Salvia haenkei 175mgThe study intervention consists of a single daily oral intake 175 mg of Salvia haenkei as soft capsule over a period of 3 months. |
| Higher dose (350mg) | Experimental | Dietary Supplement: Salvia haenkei 350mgThe study intervention consists of a single daily oral intake 350 mg of Salvia haenkei as soft capsule over a period of 3 months. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvia haenkei 175mgThe product appears as a soft gel containing the dry extract of Salvia haenkei | Dietary supplement | Lower dose (175mg) |
| Salvia haenkei 350mgThe product appears as a soft gel containing the dry extract of Salvia haenkei | Dietary supplement | Higher dose (350mg) |
Primary outcome
Occurrence of adverse events
Time frame: From Day 0 to Day 90
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.
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
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Noseda, MD, PhD principal investigator
Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvia haenkei 175mg and Salvia haenkei 350mg in people with Aging, run by IBSA Farmaceutici Italia Srl at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Terrot (+41 91 811 7962, Tatiana.Terrot@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: From Day 0 to Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.