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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    24
  • sponsor
    Rijnstate Hospital
Updated on 12 August 2021
fats
bariatric surgery
sugars

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.

Details
Condition Bariatric Surgery Candidate, Obesity, Lifestyle, adiposity
Treatment lifestyle / RYGB
Clinical Study IdentifierNCT04990947
SponsorRijnstate Hospital
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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