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

July 29, 2021 updated by: Rijnstate Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

RYGB or obesity with lifestyle intervention

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight / BMI
Time Frame: baseline, 4weeks, 3 months, 6 months, 12 months
weight and height measurements
baseline, 4weeks, 3 months, 6 months, 12 months
Drinking microstructure over time
Time Frame: baseline, 4weeks, 3 months, 6 months, 12 months
Measured with the drinkometer
baseline, 4weeks, 3 months, 6 months, 12 months
Change in self-reported hunger, thirst, fullness, preference
Time Frame: baseline, 4weeks, 3 months, 6 months, 12 months
VAS scale 0-100
baseline, 4weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-1594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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