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:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT06630312
Eligibility Criteria:
Inclusion Criteria:
* BMI between 20-29.9 kg/m2
* Height range of 60-74"
* HbA1C between 4.9-5.7%
* Individuals who consumed breakfast on most days
* Women who were not pregnant or lactating
* Individuals who could walk and eat independently
* Individuals who were willing to eat beans and bean pasta
* Individuals who were willing to restrict moderate and vigorous exercise, caffeine, alcohol, or herbal teas for 24 hours prior to testing
Exclusion Criteria:
* Persons who smoke cigarettes, tobacco of other kinds or e-cigarettes
* Vegetarian/Vegan
* Uncontrolled health conditions and/or diagnosis of gastrointestinal disease
* Intake of any medications and/or dietary supplements affecting glucose levels
* Individuals with HbA1C level \>5.9% at screening
* Individuals with an allergy to legumes, tomatoes, nus, wheat, or gluten
* Known latex allergy
* Known allergy to mold or alpha-galactosidase enzyme products
* Never had blood drawn before from arm
* Known difficulty with blood draws, e.g., feeling faint, or dizzy
* Individual who have had a recent weight gain or loss (\>10% over 6 months)
* Persons who work altered shifts
* Abnormal score on the Three-Factor Eating Questionnaire
* Unwillingness or inability to follow study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
34 Years
Study:
NCT06630312
Study Brief:
Protocol Section:
NCT06630312