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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03223935
Eligibility Criteria:
Inclusion Criteria:
* BMI: ≥18.5 and ≤29.9 kg/m2
* Fasting serum glucose: ≤5.5 mmol/L
Exclusion Criteria:
* Fasting serum glucose \> 5.5 mmol/L
* Smoking
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
* Presence of a gastrointestinal disorder or surgeries within the past year
* 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
* Known to be pregnant or lactating
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
* Weight gain or loss of at least 10lbs in previous three months
* Excessive alcohol intake
* Restrained Eaters (identified by Eating Habits Questionnaire)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03223935
Study Brief:
Protocol Section:
NCT03223935