Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-02 @ 12:16 PM
Study NCT ID:
NCT05744050
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Food Reformulation on Energy Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-21', 'size': 1931606, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-02-21T04:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Repeated measures'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute intake', 'timeFrame': '30 minutes after intervention administered', 'description': 'The investigators will observe differences in consumption (g/kcal) when participants are given a meal covertly manipulated to be low, medium or high in energy density.'}], 'secondaryOutcomes': [{'measure': 'Later intake', 'timeFrame': 'Up to 7 hours after intervention administered', 'description': 'The investigators will measure later food intake, in order to observe any evidence of later compensation in response to experimental condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet, Healthy', 'Eating Behavior', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '38825014', 'type': 'DERIVED', 'citation': 'Finlay AH, Boyland EJ, Jones A, Langfield T, Bending E, Malhi MS, Robinson E. Passive overconsumption? Limited evidence of compensation in meal size when consuming foods high in energy density: Two randomised crossover experiments. Appetite. 2024 Sep 1;200:107533. doi: 10.1016/j.appet.2024.107533. Epub 2024 Jun 1.'}]}, 'descriptionModule': {'briefSummary': "Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. A number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. However, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. However, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes.\n\nThe investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition", 'detailedDescription': 'See attached protocol document.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently reside in the United Kingdom\n* Over the age of 18 years\n* Fluent English speaker\n* Like the test foods\n* Have a BMI between the ranges of 18.5 and 35.\n\nExclusion Criteria:\n\n* Pregnant/breastfeeding\n* Partaking in a fast or other restrictive eating for religious reasons at time of participation\n* Currently following a diet\n* On medication that affects appetite\n* Being a smoker\n* Current or historic eating disorder\n* Dietary restrictions/intolerances including:\n\n * Any allergies\n * Vegan/vegetarian\n * Gluten-free\n * Dairy-free\n * Sugar-free'}, 'identificationModule': {'nctId': 'NCT05744050', 'briefTitle': 'The Impact of Food Reformulation on Energy Intake', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'The Impact of Food Reformulation on Energy Intake', 'orgStudyIdInfo': {'id': 'Reformulation study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low energy density', 'description': 'The meal served at lunch time to participants will have a low energy density of \\~1.1kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert)', 'interventionNames': ['Behavioral: Low energy density lunch']}, {'type': 'EXPERIMENTAL', 'label': 'Medium energy density', 'description': 'The meal served at lunch time to participants will have a low energy density of \\~1.7kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert)', 'interventionNames': ['Behavioral: Medium energy density lunch']}, {'type': 'EXPERIMENTAL', 'label': 'High energy density', 'description': 'The meal served at lunch time to participants will have a low energy density of \\~3kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert)', 'interventionNames': ['Behavioral: High energy density lunch']}], 'interventions': [{'name': 'Low energy density lunch', 'type': 'BEHAVIORAL', 'description': 'Particpants will be provided with a lunch low in energy density (\\~1.1kcal/g)', 'armGroupLabels': ['Low energy density']}, {'name': 'Medium energy density lunch', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided with a lunch medium in energy density(\\~1.7kcal/g)', 'armGroupLabels': ['Medium energy density']}, {'name': 'High energy density lunch', 'type': 'BEHAVIORAL', 'description': 'Participants will be provided with a lunch high in energy density (\\~3kcal/g)', 'armGroupLabels': ['High energy density']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L69 7ZA', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'University of Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Eric Robinson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/e67xg/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'On publication, indefinitely', 'ipdSharing': 'YES', 'description': 'Study data (anonymised) will be shared on the Open Science Framework (OSF)', 'accessCriteria': 'Open website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Eric Robinson', 'investigatorAffiliation': 'University of Liverpool'}}}}