ClinicalTrials.gg
CompletedNCT03363581Updated Aug 8, 2023Results posted

Food Preference Following Bariatric Surgery

An observational study in Obesity, sponsored by Imperial College London. Completed at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Obesity by Imperial College London — 5 open to participants now, 6 under way, none of them phase 3. Obesity · Imperial College London.

Started
2017
with 2 others
Observational
9 of 36
1 open now
Registered
22nd of 36
by date

Among the 36 studies in Obesity by Imperial College London, this one is one of 3 that started in 2017, is one of 9 observational ones, and was the 22nd registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

5 of the 36 studies in Obesity by Imperial College London are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Obesity

Keywords

  • Food preferences
  • Fat
  • Weight loss
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Gastric bypass

    Obese patients due to undergo gastric bypass surgery

    Behavioral: Food Preference

  • Control

    Healthy free-living individuals

    Behavioral: Food Preference

Interventions

  • BehavioralFood Preference

    Buffet meal to assess food preference

06

What researchers measure

Primary outcomes

  1. Total Food Intake (Lunch Buffet) at 24 Months

    Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. 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

    Time frame: 24 months

  4. 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

    Time frame: 24 months

  5. 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

    Time frame: 24 months

07

Results

Posted Aug 8, 2023

Participant flow

Participant flow — Overall Study
MilestoneGastric BypassHealthy Free-living Individuals
Started1420
Completed1420
Not completed00

Outcome measures

PrimaryTotal Food Intake (Lunch Buffet) at 24 Months

Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

Time frame:
24 months
Reported as:
Mean · kJ
Total Food Intake (Lunch Buffet) at 24 Months
kJGastric BypassHealthy Free-living Individuals
Total Food Intake (Lunch Buffet) at 24 Months2540.1 ± 431.0721 ± 201
PrimaryChange 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

Time frame:
24 months
Reported as:
Mean · kJ
Change in Absolute Intake of Fat
kJGastric BypassHealthy Free-living Individuals
Change in Absolute Intake of Fat-1549.7 ± 298.9301 ± 70.1
PrimaryChange 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

Time frame:
24 months
Reported as:
Mean · kJ
Change in Absolute Intake of Carbohydrates
kJGastric BypassHealthy Free-living Individuals
Change in Absolute Intake of Carbohydrates-2088.6 ± 370.1280 ± 40.3
PrimaryChange 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

Time frame:
24 months
Reported as:
Mean · kJ
Change in Absolute Intake of Sugar
kJGastric BypassHealthy Free-living Individuals
Change in Absolute Intake of Sugar-890.7 ± 258.1160.0 ± 39.8
PrimaryChange 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

Time frame:
24 months
Reported as:
Mean · kJ
Change in Absolute Intake of Protein
kJGastric BypassHealthy Free-living Individuals
Change in Absolute Intake of Protein-360.7 ± 91.4140.2 ± 35.2

Adverse events

Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gastric Bypass0/14 (0%)0/14 (0%)0/14 (0%)
Healthy Free-living Individuals0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Gastric BypassHealthy Free-living IndividualsTotal
Mean51.0 ± 7.828 ± 4.139.5 ± 5.95
Sex: Female, Male
Sex: Female, Male(Participants)Gastric BypassHealthy Free-living IndividualsTotal
Female101222
Male4812
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Gastric BypassHealthy Free-living IndividualsTotal
Hispanic or Latino000
Not Hispanic or Latino142034
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Gastric BypassHealthy Free-living IndividualsTotal
Ireland142034
Body weight (kg)
Body weight (kg)(kg)Gastric BypassHealthy Free-living IndividualsTotal
Mean136 ± 23.865 ± 5.2100.5 ± 14.5
Total Food Intake (Lunch Buffet)
Total Food Intake (Lunch Buffet)(kJ)Gastric BypassHealthy Free-living IndividualsTotal
Mean6510.3 ± 1023800 ± 503655 ± 536.5
Absolute intake of fat
Absolute intake of fat(kJ)Gastric BypassHealthy Free-living IndividualsTotal
Mean2617.1 ± 250310 ± 301448.5 ± 265
Absolute intake of carbohydrates
Absolute intake of carbohydrates(kJ)Gastric BypassHealthy Free-living IndividualsTotal
Mean3102.4 ± 1080300 ± 701701.2 ± 575

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University College Dublin
    Dublin, Ireland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Sep 2021, 45 months.

Results were first posted in Aug 2023, 1 year 10 months after primary completion.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 45 months is above that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2017
First posted
Dec 6, 2017
StartActual
Dec 15, 2017
Primary completionActual
Sep 30, 2021
CompletionActual
Sep 30, 2021
Results first posted
Aug 8, 2023
Last update
Aug 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03363581
Responsible party
Carel Le Roux (Reader in Investigative Science, Imperial College London) — Principal investigator
First posted
Dec 6, 2017
Start date
Dec 15, 2017
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Results posted
Aug 8, 2023
Last update
Aug 8, 2023

Study contacts

Carel le Roux, MBChB, PhD
principal investigator · Imperial College London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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