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

• Conditions: Lifestyle; Obesity; Bariatric Surgery Candidate
• Interventions: Other: lifestyle / RYGB

• Registration Number: NCT04990947
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-04-07
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-29
• Last Update Submitted: 2021-07-29
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• 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: 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery (Roux-en-Y Gastric Bypass)	lifestyle / RYGB	Patients who are eligible for RYGB
Lifestyle group	lifestyle / RYGB	Patients with a BMI \> 30 who will start a lifestyle program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Yonta van der Burgh; 🇳🇱 Arnhem, Netherlands