Actively Recruiting
Safety and Tolerability of Salvia Haenkei Extract as a Dietary Supplement in Healthy Adults Aged 55-65 Randomized, Open-Label Study Comparing Two Oral Doses Over Three Months
Led by IBSA Farmaceutici Italia Srl · Updated on 2025-01-23
50
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the safety and tolerability of taking Salvia haenkei, a dietary supplement, by mouth in healthy adults aged 55 to 65 years. Salvia haenkei is being studied for its potential anti-aging effects and its ability to improve muscle and organ functions such as kidney, liver, and heart health, as well as reduce inflammation and influence metabolism. Participants will receive one of two doses of Salvia haenkei dry extract in soft gel form: either 175 mg or 350 mg. The study is designed as an open-label, randomized trial with two parallel groups, each receiving a different dose to compare safety and tolerability. The treatment period lasts 90 days. During the study, participants will be closely monitored for any adverse events and their ability to tolerate the supplement without dropping out. Researchers will evaluate muscle and organ function, inflammation levels, and metabolic markers. The total duration for each participant is 90 days, during which adherence and health will be regularly assessed to ensure safety and gather information on the supplement's effects.
CONDITIONS
Official Title
Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male or female
- Age 55 to 65 years inclusive
- In good general health based on medical history and current health
- Willing to maintain usual diet and exercise habits
- Able and willing to follow study requirements
You will not qualify if you...
- Body Mass Index less than 18.5 or 30 and above
- Difficulty swallowing (dysphagia)
- Known allergy or sensitivity to study ingredients
- Any significant medical condition or abnormal lab results making participation unsuitable
- Planned major surgery during study
- Unable or contraindicated to undergo study intervention
- Unable to follow study procedures due to language, psychological, or cognitive issues
- Use of new vitamins, herbal or dietary supplements, functional foods, or sports drinks aimed at enhancing performance within one month before and during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Regionale di Lugano
Lugano, Switzerland
Actively Recruiting
Research Team
T
Tatiana Terrot
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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