Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass (NCT04600596) | Clinical Trial Compass
CompletedNot Applicable
Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass
Switzerland54 participantsStarted 2019-06-01
Plain-language summary
Direct measurements of changes in food selection in humans after RYGB have been limited by the unreliability of patients, which poses significant methodological and conceptual challenges to researchers and study design. Self-monitoring requires time and effort, and many find tracking of dietary intake tedious, which contributes to attrition. Direct measurements, however, represent an essential component in the attempt to understand how RYGB alters eating and food preferences, but laboratory settings preclude a real-life environment.
The aim of this study is to investigate changes in food preferences, total energy intake of the three primary macronutrients and meal patterns between obese women (BMI ≥ 35) before and after Roux-en-Y gastric bypass and lean (BMI ≤ 25) and obese (BMI ≥ 35) controls by means of photographic food recognition with a mobile application.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult aged \>18;
* Obese and non-obese group:
* Obese person BMI \> 35 kg/m2 with no history of bariatric surgery;
* Healthy normal weight controls (BMI \< 25 kg/m2) with no history of bariatric surgery.
* Independently mobile;
* Digital literacy;
* Ability to communicate fluently in German;
* Capacity to consent to participate;
Exclusion Criteria:
* Diabetes;
* Pregnancy/lactation;
* Inability to understand instructions;
* Systemic or gastrointestinal condition which may affect food intake or preference;
* Diabetes Mellitus (type I and II);
* Pregnancy or lactation ;
* Weight loss diet or weight gain diet;
* Active and significant psychiatric illness including substance misuse;
* Suffering from heart or kidney failure or malabsorption;
* Significant cognitive or communication issues;
* Medications with documented effect on food intake or food preference;
* History of significant food allergy and certain dietary restrictions;
* Participants who have travelled (overnight trip of more than 200 miles) within 2 weeks before or after dose administration of isotopes;
* Participants that need to have intravenous fluids during 2 weeks before and after the study period will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in total energy intake of the three primary macronutrients before and after RYGB.
Timeframe: Baseline, 3, 6, and 12 month post surgery.