ObesityNCT03363581
Food Preference Following Bariatric Surgery
An observational study of Obesity, run by Imperial College London at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Food Preference
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteIreland
- Study dates
- 15 Dec 2017to 30 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obesity attending a specialist obesity clinic and free living individuals.
Who may be able to join
- Surgical and non-surgical groups:
- Bariatric surgery B) Controls with no history of bariatric surgery
- Independently mobile
- Capacity to consent to participate
- >18 years of age
Who cannot join
- 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:
- pregnancy or ii) breast feeding.
- Active and significant psychiatric illness including substance misuse
- Significant cognitive or communication issues
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Food Preference
- Keywords
- Food preferences, Fat, Weight loss
- Medical subject headings
- Obesity, Food Preferences, Platelet Glycoprotein IV Deficiency, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food PreferenceBehavioural
Buffet meal to assess food preference
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Obese patients due to undergo gastric bypass surgery Receives: Behavioral: Food Preference | |
| Control | Healthy free-living individuals Receives: Behavioral: Food Preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Food Intake (Lunch Buffet) at 24 Months
Determine the effect of RYGB on total food intake from an ad libitum lunch buffet
Measured: 24 months
Change in Absolute Intake of Fat
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet
Measured: 24 months
Change in Absolute Intake of Carbohydrates
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet
Measured: 24 months
Change in Absolute Intake of Sugar
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet
Measured: 24 months
Change in Absolute Intake of Protein
Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start15 Dec 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carel Le Roux, Imperial College London
- Investigators
- Carel le Roux, MBChB, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363581
- Sponsor's protocol ID
- GutHormoneStudy
- Status last verified
- Oct 2022
- First submitted
- 9 Aug 2017
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Preference Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03363581
- Acronym / sponsor ID
- GutHormoneStudy
- Conditions
- Obesity
- Keywords
- Food preferences, Fat, Weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | – | Behavioral: Food PreferenceObese patients due to undergo gastric bypass surgery |
| Control | – | Behavioral: Food PreferenceHealthy free-living individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity attending a specialist obesity clinic and free living individuals.
Key inclusion criteria (5 listed)
- Surgical and non-surgical groups:
- Independently mobile
- Capacity to consent to participate
- >18 years of age
Key exclusion criteria (11 listed)
- 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:
- Active and significant psychiatric illness including substance misuse
- Significant cognitive or communication issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food PreferenceBuffet meal to assess food preference | Behavioural | Control, Gastric bypass |
Primary outcome
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carel le Roux, MBChB, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Imperial College London at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Food Intake (Lunch Buffet) at 24 Months (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.