Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05399966
Eligibility Criteria:
Inclusion Criteria:
* The subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
* Age: 45 - 65
Exclusion Criteria:
* Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular disease (e.g., stroke, heart attack))
* Chronic intake of medication/dietary supplements with impact on stress levels (psychologically and physiological)
* Consumption of any dietary/nutritional supplements or functional foods
* Smokers
* High caffeine intake \> 5 coffee cups / day
* Gastrointestinal diseases/conditions (ulcerative colitis, Crohn's disease, peptic ulcers, celiac disease)
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Known allergies against the mint family (labiate), especially lemon balm (la cedrella, la melissa, la citronella)
* Pregnancy, breastfeeding or intention to become pregnant during the study
* Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
* Blood donation within 4 weeks prior to study start (screening) or during the study
* Anticipating any planned changes in lifestyle for the duration of the study
* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT05399966
Study Brief:
Protocol Section:
NCT05399966