Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT03113305
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Ingestive Behaviour Following Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'DNA, Plasma and serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Total energy density (kJ / gram)'}], 'secondaryOutcomes': [{'measure': 'Total energy intake', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': '24-hour intake (kJ)'}, {'measure': 'Relative macronutrient intake', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': '% contribution of macronutrient to energy intake'}, {'measure': 'Food preferences', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Explicit and implicit food preferences measured by the Leeds Food Preference Questionnaire'}, {'measure': 'Eating occasion size', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Grams and kJ over 24 hour period'}, {'measure': 'Eating speed', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'g/min and kJ/min over 24 hour period'}, {'measure': 'Meal frequency', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Defined as a continuous period of feeding terminated with a pause \\>5mins'}, {'measure': 'Basal Metabolic Rate', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Measured by indirect calorimetry'}, {'measure': 'Percentage body fat', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Measured by dual X-ray absorptiometry'}, {'measure': 'Percentage lean weight', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Measured by dual X-ray absorptiometry'}, {'measure': 'Bone health', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery', 'description': 'Measured by dual X-ray absorptiometry'}, {'measure': 'Serum lipid profile', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery'}, {'measure': 'Plasma micronutrient status', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery'}, {'measure': 'Serum C-Reactive Protein', 'timeFrame': 'Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric bypass', 'Morbid obesity', 'Food choice', 'Ingestive behaviour', 'Food preference'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '36774099', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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 undertakenÍž 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planning to undergo gastric bypass surgery. Control participants with no planned weight loss/gain.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* Planned gastric bypass surgery (patients only)\n* No planned weight loss/gain (controls only)\n\nExclusion Criteria:\n\nPatients\n\n* Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal\n* Systemic or gastrointestinal condition which may affect food intake or preference\n* Pregnancy / lactation\n* Significant food allergy or dietary restriction\n* Medication with documented effect on food intake or food preference\n* Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.\n\nControls\n\n* Medication with documented effect on food intake / preference or study outcomes\n* Pregnancy / lactation\n* Significant food allergy or dietary restriction\n* Undertaking a weight-loss programme or planning to.'}, 'identificationModule': {'nctId': 'NCT03113305', 'briefTitle': 'Changes in Ingestive Behaviour Following Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': 'Changes in Ingestive Behaviour Following Gastric Bypass', 'orgStudyIdInfo': {'id': '16/WS/0056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric bypass patients', 'description': 'Patients planned to undergo Gastric bypass procedure. Patients will be assessed -1 month, 3-, 24-, 48- and 60 months post surgery.'}, {'label': 'Healthy controls', 'description': 'Healthy controls with no planned weight loss/gain. Control participant assessments will be time-matched with patients.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Letterkenny', 'country': 'Ireland', 'facility': 'Letterkenny University Hospital', 'geoPoint': {'lat': 54.95, 'lon': -7.73333}}, {'zip': 'BT52 1SA', 'city': 'Coleraine', 'state': 'Co.Londonderry', 'country': 'United Kingdom', 'facility': 'Human Intervention Studies Unit, Ulster University', 'geoPoint': {'lat': 55.13333, 'lon': -6.66667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'Letterkenny University Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}