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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01929551
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Ages 18 to 50 years
* Body mass index between 18.5 and 27.4 kilograms divided by squared meters
* Waist circumference ≤ 102 centimeters for men and ≤88 centimeters for women
* Fasting capillary glucose ≤100 milligrams per deciliter
The night before the study:
* 10 hours fasting
* Light dinner of their choice and repeat it every time before the study
* No alcohol, coffee or tea drinks the previous night
* No vigorous exercise the day before the test nor the morning of the test
Exclusion Criteria:
* Consumption of any of the following: oral hypoglycemic drugs, oral or parenteral glucocorticoid drugs, thyroid hormones, stimulant of intestinal motility or other drugs that may interfere with the intestinal absorption during the test
* Acute or chronic gastrointestinal infections
* Breast feeding or pregnant women
* Intestinal surgeries in the last 6 months
* Allergies to any of the products we will be using
* Subjects with gastrointestinal or metabolic diseases
* Subjects with first grade family history of diabetes mellitus
* Subjects with glucose intolerance, insulin resistance or diabetes mellitus
* Subjects who dislike any of the products we will be using
* Subjects with an acute (previous 24 hours) digestive crisis including: gastritis, diarrhea, and vomit, among others
* Subjects with a history of mal-absorption
Suspension:
* Subjects that do not arrive at the test-day
* Fasting glucose ≥ 100 milligrams per deciliter the day of the test
* Subjects who develop gastrointestinal disease during the study time frame
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01929551
Study Brief:
Protocol Section:
NCT01929551