NCT03113305

Changes in Ingestive Behaviour Following Gastric Bypass

Completed Last updated 29 June 2023

What this trial tests

trial in Morbid Obesity in 63 participants. Completed in 31 May 2023.

Timeline

1 September 2016

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	University of Ulster
Status	Completed
Study type	OBSERVATIONAL
Enrollment	63
Start date	1 September 2016
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	2 locations across United Kingdom, Ireland

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →

Sponsor

University of Ulster

Who can join

18 and older, any sex, with Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently.
   Livingstone MBE, Redpath T, Naseer F, Boyd A, et al · · 2022 · cited 26× · PMID 36774099 · DOI 10.1093/jn/nxac164
2. Metabolic adaptation following gastric bypass surgery: results from a 2-year observational study.
   Naseer F, Zhang SD, Miras AD, Redpath T, et al · · 2024 · cited 6× · PMID 39227457 · DOI 10.1038/s41366-024-01585-5
3. Evaluation of the impact of gastric bypass surgery on eating behaviour using objective methodologies under residential conditions: Rationale and study protocol.
   Redpath T, Naseer F, Price RK, Boyd A, et al · · 2021 · cited 5× · PMID 34646959 · DOI 10.1016/j.conctc.2021.100846
4. Metabolic adaptation following gastric bypass surgery: Results from a 2-year observational study.
   Price R, Naseer F, Zhang S, Miras A, et al · · 2024 · DOI 10.21203/rs.3.rs-3789295/v1