- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03363581
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
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
-
-
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Dublin, Ireland
- University College Dublin
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-
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:
Surgical and non-surgical groups:
A) Bariatric surgery B) Controls with no history of bariatric surgery
- Independently mobile
- Capacity to consent to participate
- >18 years of age
Exclusion Criteria:
- Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
- Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
Systemic or gastrointestinal condition which may affect food intake or preference, including:
i) pregnancy or ii) breast feeding.
- Active and significant psychiatric illness including substance misuse
- Significant cognitive or communication issues
- Medications with documented effect on food intake or food preference
- History of significant food allergy and certain dietary restrictions
- History of liver disease or pancreatitis
- History of bradyarrythmia or congestive cardiac failure group)
- 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
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Buffet meal to assess food preference
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Control
Healthy free-living individuals
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Buffet meal to assess food preference
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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
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24 months
|
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Change in Absolute Intake of Fat
Time Frame: 24 months
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Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet
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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
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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
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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
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Determine if the changes in food preference following RYGB are mediated through changes in gut peptide following surgery.
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2 weeks pre surgery and 3, 12 (two occasions) and 24 months post surgery and matched visits for controls
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Octreotide
Time Frame: 12 months post surgery and time matched controls at two occasions
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Determine the effect of gut hormone suppression (octreotide) on ad libitum macronutrient intake
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12 months post surgery and time matched controls at two occasions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
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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