CIBuS: Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
Study Details
Study Description
Brief Summary
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bariatric surgery (Roux-en-Y Gastric Bypass) Patients who are eligible for RYGB |
Other: lifestyle / RYGB
No intervention, just 2 different groups will be included
|
| Lifestyle group Patients with a BMI > 30 who will start a lifestyle program |
Other: lifestyle / RYGB
No intervention, just 2 different groups will be included
|
Outcome Measures
Primary Outcome Measures
- Changes in caloric intake [Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle]
kcal consumed
Secondary Outcome Measures
- Weight / BMI [baseline, 4weeks, 3 months, 6 months, 12 months]
weight and height measurements
- Drinking microstructure over time [baseline, 4weeks, 3 months, 6 months, 12 months]
Measured with the drinkometer
- Change in self-reported hunger, thirst, fullness, preference [baseline, 4weeks, 3 months, 6 months, 12 months]
VAS scale 0-100
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Woman
-
Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
-
Patients must be able to adhere to the study visit schedule
-
Independently mobile
-
Patients must be able to give informed consent (IC) prior to any study procedures
-
Surgical (1) and non-surgical (2) groups:
-
Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
-
Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program
Exclusion Criteria:
-
Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
-
Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
-
Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
-
Pregnancy or lactation, or planning to get pregnant during the study period
-
Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
-
Active and significant psychiatric illness including substance misuse
-
Significant cognitive or communication issues
-
Medications with documented effect on food intake or food preference
-
Participating in another scientific study at the same time, if
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonta van der Burgh | Arnhem | Netherlands | 6815 AD |
Sponsors and Collaborators
- Rijnstate Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-1594