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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT05291351
Eligibility Criteria:
Inclusion Criteria:
* 18-45 years of age
* BMI 18.5-29.9 kg/m2
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to maintain current dietary supplement use throughout the trial.
* Willing to abstain from alcohol consumption for 24h prior to all test visits.
* Willing to avoid vigorous physical activity for 24h prior to all test visits.
* Understanding the study procedure and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
* Smoking
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, a malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
* Presence of a gastrointestinal disorder or surgeries within the past year.
* Known to be pregnant or lactating.
* Unwillingness or inability to comply with the experimental procedures and to follow our safety guidelines.
* Allergies to peanuts and nuts.
* Known intolerances, sensitivity or allergy to any ingredients in the study products: pea flour, lentil flour, oat flour and whole wheat flour.
* Regular breakfast skipping (consumes breakfast less than 5 days a week)
* Extreme dietary habits (i.e Atkins diet, very high protein diets, etc.) or restrained eaters, identified by a score of ≥ 11 on the Eating Habits Questionnaire
* Uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg) as defined by the average blood pressure measured at screening.
* Weight gain or loss of at least 10lbs in previous three months.
* Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week).
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05291351
Study Brief:
Protocol Section:
NCT05291351