Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 6:36 PM
Study NCT ID:
NCT04938934
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2021-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in digestive well-being in response to a comfort meal before and after conditioning.', 'timeFrame': '120 minutes', 'description': 'Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a comfort meal before and after conditioning.'}], 'secondaryOutcomes': [{'measure': 'Difference in fullness sensation in response to a comfort meal before and after conditioning', 'timeFrame': '120 minutes', 'description': 'Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning.'}, {'measure': 'Change in mood in response to a comfort meal before and after conditioning', 'timeFrame': '120 minutes', 'description': 'Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a comfort meal before and after conditioning.'}, {'measure': 'Change in hunger/satiety in response to a comfort meal before and after conditioning', 'timeFrame': '120 minutes', 'description': 'Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a comfort meal before and after conditioning'}, {'measure': 'Change in discomfort in response to a comfort meal before and after conditioning', 'timeFrame': '120 minutes', 'description': 'Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meal ingestion', 'postprandial responses', 'hedonic sensations', 'homeostatic sensations', 'Conditioning'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32252402', 'type': 'BACKGROUND', 'citation': 'Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.'}, {'pmid': '33801924', 'type': 'BACKGROUND', 'citation': 'Livovsky DM, Azpiroz F. Gastrointestinal Contributions to the Postprandial Experience. Nutrients. 2021 Mar 10;13(3):893. doi: 10.3390/nu13030893.'}, {'pmid': '33670508', 'type': 'BACKGROUND', 'citation': 'Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.'}, {'pmid': '37242129', 'type': 'DERIVED', 'citation': 'Nieto A, Livovsky DM, Azpiroz F. Conditioning by a Previous Experience Impairs the Rewarding Value of a Comfort Meal. Nutrients. 2023 May 9;15(10):2247. doi: 10.3390/nu15102247.'}]}, 'descriptionModule': {'briefSummary': 'Meal ingestion induces sensations that are influenced by a series of conditioning factors.\n\nAim: to determine the conditioning effect of previous digestive symptoms to a standardized probe meal.\n\nControlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).\n\nParticipants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-obese\n\nExclusion Criteria:\n\n* history of gastrointestinal symptoms\n* prior obesity\n* use of medications\n* history of anosmia and ageusia\n* current dieting\n* alcohol abuse\n* psychological disorders\n* eating disorders'}, 'identificationModule': {'nctId': 'NCT04938934', 'briefTitle': 'Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Factors That Determine the Responses to Meal Ingestion: Conditioning Effect of Previous Symptoms', 'orgStudyIdInfo': {'id': 'PR(AG)338/2016M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aversive conditioning', 'interventionNames': ['Behavioral: Lipids infusion']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham conditioning', 'interventionNames': ['Behavioral: Sham infusion']}], 'interventions': [{'name': 'Lipids infusion', 'type': 'BEHAVIORAL', 'description': 'Lipids infusion via intestinal tube', 'armGroupLabels': ['Aversive conditioning']}, {'name': 'Sham infusion', 'type': 'BEHAVIORAL', 'description': 'Sham infusion via intestinal tube', 'armGroupLabels': ['Sham conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}