Evaluating the safety of Salvia haenkei as a dietary supplement
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
NA · IBSA Farmaceutici Italia Srl · NCT05936346
This study is testing whether taking Salvia haenkei as a dietary supplement is safe for healthy people aged 55 to 65 and if it can help improve their organ functions and overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Sponsor | IBSA Farmaceutici Italia Srl (industry) |
| Locations | 1 site (Lugano) |
| Trial ID | NCT05936346 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and tolerability of Salvia haenkei when taken orally by healthy individuals aged 55 to 65. It aims to explore the potential anti-aging effects of this supplement on various organ functions, including muscular, kidney, liver, and heart functions, as well as its impact on systemic inflammation and metabolism. Participants will receive either 175mg or 350mg of Salvia haenkei and will be monitored for any adverse effects throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 55 to 65 who are willing to maintain their current dietary and exercise habits.
Not a fit: Patients with a Body Mass Index outside the range of 18.5 to 30 or those with significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary supplement option to help counteract aging and improve overall health in older adults.
How similar studies have performed: While there is limited data on Salvia haenkei specifically, other studies on dietary supplements targeting aging have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lugano
- Ospedale Regionale di Lugano — Lugano, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Roberta Noseda, MD, PhD — Istituto di Scienze Farmacologiche della Svizzera Italiana, Lugano (Switzerland)
- Study coordinator: Tatiana Terrot
- Email: Tatiana.Terrot@eoc.ch
- Phone: +41 91 811 7962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aging