Changes in Ingestive Behaviour Following Gastric Bypass

June 28, 2023 updated by: University of Ulster

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Letterkenny, Ireland
        • Letterkenny University Hospital
  • United Kingdom
    • Co.Londonderry
      • Coleraine, Co.Londonderry, United Kingdom, BT52 1SA
        • Human Intervention Studies Unit, Ulster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Food intake
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Total energy density (kJ / gram)
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total energy intake
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
24-hour intake (kJ)
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Relative macronutrient intake
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
% contribution of macronutrient to energy intake
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Food preferences
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
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Eating occasion size
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Grams and kJ over 24 hour period
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Eating speed
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
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Meal frequency
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
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Basal Metabolic Rate
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by indirect calorimetry
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Percentage body fat
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Percentage lean weight
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Bone health
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Measured by dual X-ray absorptiometry
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Serum lipid profile
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Plasma micronutrient status
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Serum C-Reactive Protein
Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Florida
University College Dublin
Letterkenny University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16/WS/0056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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