Actively Recruiting

Phase Not Applicable
Age: 55Years - 65Years
All Genders
Healthy Volunteers
ID05936346

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

Age: 55Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Ospedale Regionale di Lugano

Lugano, Switzerland

Actively Recruiting

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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

Frequently Asked Questions

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