Morbid ObesityNCT03113305
Changes in Ingestive Behaviour Following Gastric Bypass
An observational study of Morbid Obesity, run by University of Ulster at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2016to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 planning to undergo gastric bypass surgery. Control participants with no planned weight loss/gain.
Who may be able to join
- >18 years
- Planned gastric bypass surgery (patients only)
- No planned weight loss/gain (controls only)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
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.
- Conditions
- Morbid Obesity
- Keywords
- Gastric bypass, Morbid obesity, Food choice, Ingestive behaviour, Food preference
- Medical subject headings
- Obesity, Morbid, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Total energy density (kJ / gram)
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Secondary outcomes (13)
Total energy intake
24-hour intake (kJ)
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Relative macronutrient intake
% contribution of macronutrient to energy intake
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Food preferences
Explicit and implicit food preferences measured by the Leeds Food Preference Questionnaire
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Eating occasion size
Grams and kJ over 24 hour period
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Eating speed
g/min and kJ/min over 24 hour period
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Meal frequency
Defined as a continuous period of feeding terminated with a pause >5mins
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Basal Metabolic Rate
Measured by indirect calorimetry
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Percentage body fat
Measured by dual X-ray absorptiometry
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Percentage lean weight
Measured by dual X-ray absorptiometry
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Bone health
Measured by dual X-ray absorptiometry
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Serum lipid profile
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Plasma micronutrient status
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Serum C-Reactive Protein
Measured: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Sep 2016
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, University of Florida, Letterkenny University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113305
- Sponsor's protocol ID
- 16/WS/0056
- Status last verified
- Jun 2023
- First submitted
- 6 Apr 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Livingstone MBE, Redpath T, Naseer F, Boyd A, Martin M, Finlayson G, Miras AD, Bodnar Z, Kerrigan D, Pournaras DJ, le Roux CW, Spector AC, Price RK. Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently. J Nutr. 2022 Nov;152(11):2319-2332. doi: 10.1093/jn/nxac164. Epub 2022 Jul 23.
PubMed 36774099
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ingestive Behaviour Following Gastric Bypass
- ClinicalTrials.gov ID
- NCT03113305
- Acronym / sponsor ID
- 16/WS/0056
- Conditions
- Morbid Obesity
- Keywords
- Gastric bypass, Morbid obesity, Food choice, Ingestive behaviour, Food preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University College Dublin, University of Florida, Letterkenny University Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planning to undergo gastric bypass surgery. Control participants with no planned weight loss/gain.
Key inclusion criteria (3 listed)
- >18 years
- Planned gastric bypass surgery (patients only)
- No planned weight loss/gain (controls only)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Food intake
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Total energy density (kJ / gram)
13 secondary outcomes
Total energy intake
Time frame: 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
Food preferences
Time frame: 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
Eating speed
Time frame: 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
Basal Metabolic Rate
Time frame: 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
Percentage lean weight
Time frame: 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
Serum lipid profile
Time frame: 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
Serum C-Reactive Protein
Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 36774099Livingstone MBE, Redpath T, Naseer F, Boyd A, Martin M, Finlayson G, Miras AD, Bodnar Z, Kerrigan D, Pournaras DJ, le Roux CW, Spector AC, Price RK. Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently. J Nutr. 2022 Nov;152(11):2319-2332. doi: 10.1093/jn/nxac164. Epub 2022 Jul 23.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by University of Ulster at 2 sites in 2 countries.
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 3 inclusion and 12 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Food intake (time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113305, which also lists 1 linked publication.
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 29 Jun 2023.