Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Daily Food Choices in Mini-Gastric Bypass
NCT04442139
Bariatric Surgery Candidate, Behavior
Khanna, Punjab, India
View Trial DetailsNCT Number: NCT03113305
The gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. A number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. However, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions.
The current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. Patients (n=32) with a planned gastric bypass procedure will be recruited from Phoenix Health (Ireland and England) and Letterkenny University Hospital (Ireland), alongside control participants (n=32) with no planned weight loss. All subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). Study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. On each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). Changes in all ingestive behaviours will be evaluated over time as compared to the control participants.
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Notify Me18 year and older
All sexes
Observational
Letterkenny University Hospital, Letterkenny, Ireland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients
Controls
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Total energy density (kJ / gram)
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
24-hour intake (kJ)
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
% contribution of macronutrient to energy intake
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Explicit and implicit food preferences measured by the Leeds Food Preference Questionnaire
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Grams and kJ over 24 hour period
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
g/min and kJ/min over 24 hour period
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Defined as a continuous period of feeding terminated with a pause >5mins
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by indirect calorimetry
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
University of Ulster
Other
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