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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	10 July 2023
Main ID:	NCT03113305
Date of registration:	06/04/2017
Prospective Registration:	No
Primary sponsor:	University of Ulster
Public title:	Changes in Ingestive Behaviour Following Gastric Bypass
Scientific title:	Changes in Ingestive Behaviour Following Gastric Bypass
Date of first enrolment:	September 1, 2016
Target sample size:	63
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03113305
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Ireland	United Kingdom

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- >18 years

- Planned gastric bypass surgery (patients only)

- No planned weight loss/gain (controls only)

Exclusion Criteria:

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

- 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Morbid Obesity

Intervention(s)

Primary Outcome(s)

Food intake [Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

Secondary Outcome(s)

Basal Metabolic Rate [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]

Food preferences [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]

Percentage body fat [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]

Serum lipid profile [Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

Total energy intake [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]

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]

Serum C-Reactive Protein [Time Frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

Secondary ID(s)

16/WS/0056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Letterkenny University Hospital

University College Dublin

University of Florida

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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