Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

Rijnstate Hospital1 site in 1 country24 target enrollmentApril 7, 2021

ConditionsBariatric Surgery Candidate Lifestyle Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bariatric Surgery Candidate
Sponsor: Rijnstate Hospital
Enrollment: 24
Locations: 1
Primary Endpoint: Changes in caloric intake
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 7, 2021

End Date

December 31, 2023

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Rijnstate Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

Changes in caloric intake

Time Frame: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle

kcal consumed

Secondary Outcomes

Weight / BMI(baseline, 4weeks, 3 months, 6 months, 12 months)
Drinking microstructure over time(baseline, 4weeks, 3 months, 6 months, 12 months)
Change in self-reported hunger, thirst, fullness, preference(baseline, 4weeks, 3 months, 6 months, 12 months)