Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07178405
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Meal Characteristics on Appetite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092965', 'term': 'Food, Processed'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '2\\*2 factorial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': 'Baseline until 1 hour, or completion of the meal (which ever comes first)', 'description': 'Energy intake estimated by nutrient calculation of leftover food'}, {'measure': 'Eating rate', 'timeFrame': 'Baseline until 1 hour, or completion of the meal (which ever comes first)', 'description': 'Time it takes to eat the study meal until satisfied'}], 'secondaryOutcomes': [{'measure': 'Self-reported appetite', 'timeFrame': 'Before, and after the meal (before meal and after 30 minutes, 1hour, 1.5 hours, 2 hours and 4 hours)', 'description': 'Self-reported appetite, using Visual Analogue Scales'}, {'measure': 'Self-reported prospective energy intake', 'timeFrame': 'From 30 min until midnight or bedtime (which ever comes first)', 'description': 'Self-reported prospective energy intake during the remainder of the day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Appetite', 'Diet', 'Intervention', 'Single meal study'], 'conditions': ['Obesity and Obesity-related Medical Conditions', 'Appetite']}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is to determine effects of different meal characteristics on energy intake, eating rate and appetite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-64 years\n* Body mass index (BMI) 18.5-35.0 kg/m2\n* Weight stability the last 3 months +/-5%\n\nExclusion Criteria:\n\n* Food allergies, intolerances or preferences preventing consumption of any products included in the study.\n* Unable to sufficiently understand written and spoken Swedish or English to provide written consent and understand information and instructions from the study personal.\n* Pregnant, lactating or planning a pregnancy during the study period.\n* History of stomach or gastrointestinal conditions or major gastrointestinal surgery (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)\n* Type 1 diabetes or type 2 diabetes.\n* Drug treated thyroid disorder\n\n •- Following any weight reduction program or having followed one during the last 6 months prior to screening.\n* Medication for weight reduction purpose effecting appetite or fat absorption (e.g. GLP-1 analogues, orlistat)\n* Severe dysfunctional eating behavior based on Three Factor Eating Questionnaire"}, 'identificationModule': {'nctId': 'NCT07178405', 'briefTitle': 'Effects of Meal Characteristics on Appetite', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Effects of Meal Characteristics on Appetite: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-02415-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LL', 'description': 'Meal low in energy density, low in ultra-processed food', 'interventionNames': ['Other: Meal low in energy density, low in ultra-processed food']}, {'type': 'EXPERIMENTAL', 'label': 'LH', 'description': 'Meal low in energy density, high in ultra-processed food', 'interventionNames': ['Other: Meal low in energy density, high in ultra-processed food']}, {'type': 'EXPERIMENTAL', 'label': 'HL', 'description': 'Meal high in energy density, low in ultra-processed food', 'interventionNames': ['Other: Meal high in energy density, low in ultra-processed food']}, {'type': 'EXPERIMENTAL', 'label': 'HH', 'description': 'Meal high in energy density, high in ultra-processed food', 'interventionNames': ['Other: Meal high in energy density, high in ultra-processed food']}], 'interventions': [{'name': 'Meal low in energy density, low in ultra-processed food', 'type': 'OTHER', 'otherNames': ['LL'], 'description': 'Meal low in energy density, low in ultra-processed food', 'armGroupLabels': ['LL']}, {'name': 'Meal low in energy density, high in ultra-processed food', 'type': 'OTHER', 'otherNames': ['LH'], 'description': 'Meal low in energy density, high in ultra-processed food', 'armGroupLabels': ['LH']}, {'name': 'Meal high in energy density, low in ultra-processed food', 'type': 'OTHER', 'otherNames': ['HL'], 'description': 'Meal high in energy density, low in ultra-processed food', 'armGroupLabels': ['HL']}, {'name': 'Meal high in energy density, high in ultra-processed food', 'type': 'OTHER', 'otherNames': ['HH'], 'description': 'Meal high in energy density, high in ultra-processed food', 'armGroupLabels': ['HH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40530', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Linnea Bärebring, PhD, Associate professor', 'role': 'CONTACT', 'email': 'linnea.barebring@gu.se', 'phone': '+46317863771'}, {'name': 'Therese Karlsson, PhD', 'role': 'CONTACT', 'email': 'therese.karlsson@gu.se', 'phone': '+4631-7863281'}], 'facility': 'University of Gothenburg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Linnea Bärebring, PhD, Associate professor', 'role': 'CONTACT', 'email': 'linnea.barebring@gu.se', 'phone': '+46317863771'}, {'name': 'Therese Karlsson, PhD', 'role': 'CONTACT', 'email': 'therese.karlsson@gu.se', 'phone': '+4631-786 32 81'}], 'overallOfficials': [{'name': 'Linnea Bärebring, PhD, Associate professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Ethical approvals and legal issues must be considered and resolved before data of individuals can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}