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

Rijnstate Hospital

Status: Unknown

Conditions: Lifestyle; Bariatric Surgery Candidate; Obesity

Treatments: Other: lifestyle / RYGB

Study type: Observational

Funder types: Other

Identifiers

NCT04990947

2020-1594

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Bariatric surgery (Roux-en-Y Gastric Bypass)

Description:

Patients who are eligible for RYGB

Treatment:

Other: lifestyle / RYGB

Lifestyle group

Description:

Patients with a BMI \> 30 who will start a lifestyle program

Treatment:

Other: lifestyle / RYGB