Direct measurement of changes in food intake behaviour in obese women after bariatric surgery or lifestyle interventio

Recruiting

• Conditions: 10003018; overweight; obesitas; morbid obesity

• Registration Number: NL-OMON49513
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

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:
1. Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated
bariatric surgery operation in agreement with the IFSO criteria)
2. 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
o Significant dysphagia
o Gastric outlet obstruction
o Anything factor that prevents subjects from drinking or eating a meal
• Post-operatively: Factors impairing ability to consume meal such as
o Significant and persistent surgical complications or
o 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 study
procedures of one of the
studies may affect the outcome in the other study.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified