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:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT03573258
Eligibility Criteria:
Inclusion criteria:
* Morbidly obese patients undergoing RYGB surgery
* Male or female, age 18 or over
* Sufficient understanding of the German language
* Understand the procedures and the risks associated with the study
* Willing to adhere to the protocol and sign the consent form (dietary/physical restrictions are a) no alcohol and no xanthine-containing liquids such as coffee, black or green tea, cola, red bull, chocolate 24 h before the study sessions. b) an identical dinner the evening before the study sessions followed by fasting overnight with no additional food or fluid except water. c) no strenuous exercise for 24 h before each treatment)
* Independently mobile
Exclusion Criteria:
* Pregnancy or lactation (as determined by questionnaire and/or pregnancy test)
* Active and significant psychiatric illness including substance misuse
* Significant cognitive or communication issues
* Medications with documented effect on food intake or food preference
* History of significant food allergy and certain dietary restrictions (e.g. Lactose intolerance)
* Participation in another clinical trial (currently or within the last 30 days)
* Smoking
* Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
* Consumption of high fiber diets (e.g. vegans, etc.) or fiber supplements or pre and probiotics
* Pre-operatively: Factors impairing ability to consume a meal such as significant dysphagia, gastric outlet obstruction, or any other factor that prevents subjects from drinking or eating a meal
* Post-operatively: Factors impairing the ability to consume meal such as significant and persistent surgical complications, any other factors that prevents subjects from drinking or eating a meal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03573258
Study Brief:
Protocol Section:
NCT03573258