Clinical trial NCT03113305: Changes in Ingestive Behaviour Following Gastric Bypass
Official title: Changes in Ingestive Behaviour Following Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Gastric bypass
Morbid obesity
Food choice
Ingestive behaviour
Food preference
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: University of Florida
name: Letterkenny University Hospital
First posted: 2017-04-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planning to undergo gastric bypass surgery. Control participants with no planned weight loss/gain.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Planned gastric bypass surgery (patients only)
* No planned weight loss/gain (controls only)

Exclusion Criteria:

Patients

* Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal
* Systemic or gastrointestinal condition which may affect food intake or preference
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Medication with documented effect on food intake or food preference
* Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.

Controls

* Medication with documented effect on food intake / preference or study outcomes
* Pregnancy / lactation
* Significant food allergy or dietary restriction
* Undertaking a weight-loss programme or planning to.

Primary outcomes:
measure: Food intake
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary outcomes:
measure: Total energy intake
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Relative macronutrient intake
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Food preferences
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Eating occasion size
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Eating speed
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Meal frequency
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Basal Metabolic Rate
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Percentage body fat
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Percentage lean weight
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Bone health
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Serum lipid profile
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Plasma micronutrient status
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
measure: Serum C-Reactive Protein
timeFrame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Other outcomes:
Locations:
city: Letterkenny
country: Ireland
facility: Letterkenny University Hospital
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References:
citation: Livingstone MBE, Redpath T, Naseer F, Boyd A, Martin M, Finlayson G, Miras AD, Bodnar Z, Kerrigan D, Pournaras DJ, le Roux CW, Spector AC, Price RK. Food intake following gastric bypass surgery: patients eat less but do not eat differently. J Nutr. 2022 Jul 23;152(11):2319-32. doi: 10.1093/jn/nxac164. Online ahead of print.