To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Changes in caloric intake from sugar and fat for the bariatric surgery
groups compared to the lifestyle group before and after treatment.
Secondary outcome
Changes in cumulative caloric intake as well as changes in cumulative caloric
intake from all macronutrients (carbohydrates, including sugar, fat and
protein) for each group over time.
Differences in caloric intake will be correlated with % weight loss at one year
after the surgery or lifestyle intervention.
Aditionally, drinking microstructure over time will be assessed and we will
make comparisons between groups.
Changes in food preference in each group over time for sweetness and fattiness
obtained from questionnaire, compared with the Drinkometer results.
Background summary
Bariatric surgery is the most effective long-term strategy to reduce weight and
maintain weight loss in patients with morbid obesity. Changes in diet selection
have been implicated as an important candidate mechanism. Patients prefer
low-sugar low-fat food and generally report finding food less enjoyable after
bariatric surgery when compared to preoperatively. However, the empirical
support for this is controversial and largely based on
indirect measures such as self-reported food intake data which has been shown
to be prone to inaccuracy due to its subjective character. Therefore, the
interaction of bariatric surgery and food choice remains to be tested with
direct measures of dietary intake and eating behaviour. We aim to use a direct
microstructural analysis of food preference to test the hypothesis that
bariatric surgery decreases relative caloric intake of stimuli with high-fat/
high-sucrose content in favour of stimuli lower in fat and sucrose content
without fundamentally modulating the palatability of these foods and fluids.
Bariatric patients will be compared to a lifestyle intervention group to
compare the effect of surgery and lifestyle advice on changes in intake
behaviour.
Study objective
To assess changes in food intake and food preference (e.g., fat and sugar)
after bariatric surgery.
Study design
Prospective observational study of patients before and after bariatric surgery
or combined lifestyle intervention. Patients will attend 5 drinkometer tests,
one time before surgery or lifestyle intervention and 4 times during the first
year of follow-up. With the drinkometer test patients get four types of drinks,
varying in sugar and fat content.
Study burden and risks
The measurements are non-invasive and carry minimal risk. Moreover, the
measurements will be combined with the regular follow-up visits as much as
possible, patients only will have no extra visits to the outpatient clinic. The
study is non-therapeutic.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73537.091.20 |