Food Preference Following Bariatric Surgery

October 3, 2022 updated by: Carel Le Roux, Imperial College London
Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. If true, this could conceivably contribute to improved glycemia and body weight. Disparities among studies on food selection and intake are likely due to the almost complete reliance on self-reported food intake which is vulnerable to inaccuracy.This controversy can best be resolved by complementing existing findings with direct measures of target behaviour in humans. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Study Type

Observational

Enrollment (Actual)

34

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

      • Dublin, Ireland
        • University College Dublin

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with obesity attending a specialist obesity clinic and free living individuals.

Description

Inclusion Criteria:

  1. Surgical and non-surgical groups:

    A) Bariatric surgery B) Controls with no history of bariatric surgery

  2. Independently mobile
  3. Capacity to consent to participate
  4. >18 years of age

Exclusion Criteria:

  1. Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
  2. Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
  3. Systemic or gastrointestinal condition which may affect food intake or preference, including:

    i) pregnancy or ii) breast feeding.

  4. Active and significant psychiatric illness including substance misuse
  5. Significant cognitive or communication issues
  6. Medications with documented effect on food intake or food preference
  7. History of significant food allergy and certain dietary restrictions
  8. History of liver disease or pancreatitis
  9. History of bradyarrythmia or congestive cardiac failure group)
  10. Use of medications with potential serious interactions with Octreotide

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric bypass
Obese patients due to undergo gastric bypass surgery
Buffet meal to assess food preference
Control
Healthy free-living individuals
Buffet meal to assess food preference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Food Intake (Lunch Buffet) at 24 Months
Time Frame: 24 months
Determine the effect of RYGB on total food intake from an ad libitum lunch buffet
24 months
Change in Absolute Intake of Fat
Time Frame: 24 months
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet
24 months
Change in Absolute Intake of Carbohydrates
Time Frame: 24 months
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet
24 months
Change in Absolute Intake of Sugar
Time Frame: 24 months
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet
24 months
Change in Absolute Intake of Protein
Time Frame: 24 months
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Hormones
Time Frame: 2 weeks pre surgery and 3, 12 (two occasions) and 24 months post surgery and matched visits for controls
Determine if the changes in food preference following RYGB are mediated through changes in gut peptide following surgery.
2 weeks pre surgery and 3, 12 (two occasions) and 24 months post surgery and matched visits for controls
Octreotide
Time Frame: 12 months post surgery and time matched controls at two occasions
Determine the effect of gut hormone suppression (octreotide) on ad libitum macronutrient intake
12 months post surgery and time matched controls at two occasions

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Carel le Roux, MBChB, PhD, Imperial College London

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)

December 15, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GutHormoneStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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