Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-05 @ 12:48 PM
Study NCT ID:
NCT03383250
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2017-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Response to Meal Ingestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolomic response in serum', 'timeFrame': '30 min'}], 'secondaryOutcomes': [{'measure': 'Change in digestive well-being measured after the test meal', 'timeFrame': '1 day', 'description': 'Change in average well-being measured by 10 score scales at the end of the test meal.'}, {'measure': 'Change in satiety measured after the test meal', 'timeFrame': '1 day', 'description': 'Change in average satiety measured by 10 score scales at the end of the test meal'}, {'measure': 'Change in fullness sensation measured after the test meal', 'timeFrame': '1 day', 'description': 'Change in average fullness measured by 10 score scales at the end of the test meal'}, {'measure': 'Change in abdominal discomfort/pain sensation measured after the test meal', 'timeFrame': '1 day', 'description': 'Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal'}, {'measure': 'Change in mood measured after the test meal', 'timeFrame': '1 day', 'description': 'Change in average mood measured by 10 score scales at the end of the test meal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meal ingestion', 'postprandial sensations', 'circulating metabolites'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.'}, 'eligibilityModule': {'sex': 'MALE', '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': 'NCT03383250', 'briefTitle': 'Metabolomic Response to Meal Ingestion', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites', 'orgStudyIdInfo': {'id': 'PR(AG)338/2016D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal ingestion', 'interventionNames': ['Dietary Supplement: Normal meal']}], 'interventions': [{'name': 'Normal meal', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Meal ingestion']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}