Changes in Ingestive Behaviour Following Gastric Bypass

Morbid Obesity Clinical Trial

Official title:

Changes in Ingestive Behaviour Following Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113305
• Other study ID #: 16/WS/0056
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Ireland	Letterkenny University Hospital	Letterkenny
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (4)

Lead Sponsor	Collaborator
University of Ulster	Letterkenny University Hospital, University College Dublin, University of Florida

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake	Total energy density (kJ / gram)	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Total energy intake	24-hour intake (kJ)	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Relative macronutrient intake	% contribution of macronutrient to energy intake	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Food preferences	Explicit and implicit food preferences measured by the Leeds Food Preference Questionnaire	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Eating occasion size	Grams and kJ over 24 hour period	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Eating speed	g/min and kJ/min over 24 hour period	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Meal frequency	Defined as a continuous period of feeding terminated with a pause >5mins	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Basal Metabolic Rate	Measured by indirect calorimetry	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Percentage body fat	Measured by dual X-ray absorptiometry	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Percentage lean weight	Measured by dual X-ray absorptiometry	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Bone health	Measured by dual X-ray absorptiometry	Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Serum lipid profile		Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Plasma micronutrient status		Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary	Serum C-Reactive Protein		Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery