Changes in Ingestive Behaviour Following Gastric Bypass

NCT03113305 | Completed

• 1 other identifier: 16/WS/0056
• Study Type: observational
• Target: 63
• Locations: 2 countries
• Sites: 2

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.

Conditions

Morbid Obesity

Keywords

Gastric bypass; Morbid obesity; Food choice; Ingestive behaviour; Food preference

Outcome Measures

Primary Outcomes (1)

• Food intake

  Total energy density (kJ / gram)

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Secondary Outcomes (13)

• Total energy intake

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

• Relative macronutrient intake

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

• Food preferences

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

• Eating occasion size

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

• Eating speed

  Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Study Arms (2)

Gastric bypass patients

Patients planned to undergo Gastric bypass procedure. Patients will be assessed -1 month, 3-, 24-, 48- and 60 months post surgery.

Healthy controls

Healthy controls with no planned weight loss/gain. Control participant assessments will be time-matched with patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planning to undergo gastric bypass surgery. Control participants with no planned weight loss/gain.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• University College Dublin: collaborator
• University of Florida: collaborator
• Letterkenny University Hospital: collaborator

Study Sites (2)

Letterkenny University Hospital

Letterkenny, Ireland

Location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Location

Related Publications (1)

• 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 Nov;152(11):2319-2332. doi: 10.1093/jn/nxac164. Epub 2022 Jul 23.

  PMID: 36774099 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

DNA, Plasma and serum samples

MeSH Terms

Conditions

Obesity, Morbid; Food Preferences

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 13, 2017
• Study Start: September 1, 2016
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); IE (1)