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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05075720
Eligibility Criteria:
Inclusion Criteria:
The recruitment will be as inclusive as possible so that the results are relevant to much of the general population. Twenty-five men and women will be recruited from the Perth general population according to the following criteria:
* aged between 18 to 70 years old
* healthy, ambulant, community-dwelling
* with no history of major chronic disease
Exclusion Criteria:
Individuals volunteering to participate in the study will be excluded according to the following criteria:
* current or recent (\<12 months) smoking
* body mass index (BMI) \<18 or \> 35 kg/m2
* systolic blood pressure \> 160 mmHg
* diastolic blood pressure \> 100 mmHg
* any major illness such as cancer, psychiatric illness, diagnosed diabetes
* use of any of the following medications: statins, antihypertensives, nitric oxide donors, antithrombotic medication, anti-coagulant medication, anti-arrhythmic drugs, beta-blockers, regular aspirin use, regular proton pump inhibitor use
* alcohol consumption \> 30g/day
* who are pregnant, lactating, or wishing to become pregnant during the study
* use of antibiotics within the previous 12 weeks of the study
* regular use of mouthwash and not willing to cease mouthwash use for the duration of the study
* participation on other research studies
* major gastrointestinal tract condition e.g. Crohns disease and inflammatory bowel disease
* and inability or unwillingness to follow the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05075720
Study Brief:
Protocol Section:
NCT05075720