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 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT05111392
Eligibility Criteria:
Inclusion Criteria:
* Have a BMI of 18.5 to 29.9 kg/m2.
* Be normotensive (\<120/80 mm Hg).
* Must be able to speak and read English.
* Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial.
* Fast for at least 8 hours prior to and through the study trial.
* Be able to abstain from alcohol for 48 h prior to each study.
* Be able to abstain from caffeine for 24 h prior to each study.
* If female, must have regular menstrual cycles, that are \> 27 days and \< 35 days in length.
Exclusion Criteria:
* Under 18 y of age or over 45 y of age.
* Have a BMI \<18.5 or \>30.
* Being pregnant.
* Lactating.
* Tobacco user.
* Have hypotension or hypertension.
* Have any type of kidney disease or dysfunction.
* Have diabetes.
* Have any type of cardiovascular disease.
* Have been diagnosed with galactosemia.
* Females with irregular menstrual cycles.
* Females with polycystic ovary disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05111392
Study Brief:
Protocol Section:
NCT05111392