Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 4:16 PM
Study NCT ID:
NCT03431233
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2018-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Premeal Protein-bar on Food Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': '120min', 'description': 'grams and caloric intake of standardized gimbap'}], 'secondaryOutcomes': [{'measure': 'Appetite (visual analogue scale : score 1 to 10)', 'timeFrame': '120min', 'description': '(1: I am not hungry at all, 10: I have never been more hungry)'}, {'measure': 'Satiety (visual analogue scale : score 1 to 10)', 'timeFrame': '120min'}, {'measure': 'plasma glucose (mmol/L)', 'timeFrame': '-15min, 0(breakfast), 30, 60, 90, 120 min', 'description': 'plasma level of glucose'}, {'measure': 'plasma active/total GLP-1 (pmol/L)', 'timeFrame': '-15min, 0(breakfast), 30, 60, 90, 120 min', 'description': 'plasma level of active/total GLP-1'}, {'measure': 'plasma active ghrelin (ng/ml)', 'timeFrame': '-15min, 0(breakfast), 30, 60, 90, 120 min', 'description': 'plasma level of active ghrelin'}, {'measure': 'plasma total peptide YY (pg/ml)', 'timeFrame': '-15min, 0(breakfast), 30, 60, 90, 120 min', 'description': 'plasma level of peptide YY'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['protein-enriched bar', 'food intake', 'appetite', 'satiety related hormones'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.', 'detailedDescription': 'Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * BMI 18.5\\~35 kg/m2\n * Never diagnosed by diabetes\n * Fasting plasma glucose \\<=100mg/dl and HbA1c \\<6.0%\n* Exclusion Criteria:\n\n * Those who diagnosed by Type 1 or Type 2 diabetes\n * Allergy to wheat, flour, nuts, milk\n * Pregnancy/lactation\n * AST or ALT \\>2.5 times of upper normal reference range\n * eGFR \\<30 mL/min/1.73m2\n * Hb \\<10g/dl\n * History of GI surgery (except hemorrhoidectomy, appendectomy)'}, 'identificationModule': {'nctId': 'NCT03431233', 'briefTitle': 'Effect of Premeal Protein-bar on Food Intake', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects', 'orgStudyIdInfo': {'id': 'H-1705-091-855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'protein enriched bar-\\>commercial cereal bar-\\>water', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'protein enriched bar-\\>water-\\>commercial cereal bar', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'commercial cereal bar-\\>protein enriched bar-\\>water', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'commercial cereal bar-\\>water-\\>protein enriched bar', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'water-\\>protein enriched bar-\\>commercial cereal bar', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': 'water-\\>commercial cereal bar-\\>protein enriched bar', 'interventionNames': ['Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water']}], 'interventions': [{'name': 'Protein-enriched bar, commercial cereal bar, or water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Min Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Min Cho', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}