Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 12:23 PM
Study NCT ID:
NCT02064205
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Appetite Suppression Trial With Polydextrose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C033375', 'term': 'polydextrose'}, {'id': 'D066248', 'term': 'High Fructose Corn Syrup'}], 'ancestors': [{'id': 'D000073417', 'term': 'Dietary Sugars'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D064427', 'term': 'Nutritive Sweeteners'}, {'id': 'D013549', 'term': 'Sweetening Agents'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wilrike.pasman@tno.nl', 'phone': '+31888665129', 'title': 'W.J. Pasman, PhD', 'organization': 'TNO'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the conduct of the study; June - November 2014', 'eventGroups': [{'id': 'EG000', 'title': 'Condition A', 'description': 'Breakfast with preload of yogurt and polydextrose', 'otherNumAtRisk': 32, 'otherNumAffected': 5, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Condition B', 'description': 'Breakfast with preload of yogurt and glucose control', 'otherNumAtRisk': 32, 'otherNumAffected': 5, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Condition C', 'description': 'Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose', 'otherNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Condition D', 'description': 'Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup', 'otherNumAtRisk': 32, 'otherNumAffected': 2, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Presyncope (light headedness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia (fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydextrose Syrup at Breakfast [A]', 'description': 'Breakfast with pre-load four hours before lunch\n\n12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch.'}, {'id': 'OG001', 'title': 'Glucose Syrup at Breakfast (Control) [B]', 'description': 'Breakfast with control pre-load four hours before lunch\n\nYogurt with control (glucose syrup) is tested for its satiating effect.\n\nglucose syrup: Glucose syrup is used a control product for the polydextrose'}, {'id': 'OG002', 'title': 'Pre-load With Polydextroseglucose Before Lunch [C]', 'description': 'Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.\n\n12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch.'}, {'id': 'OG003', 'title': 'Pre-load With Yogurt and Glucose Before Lunch [D]', 'description': 'Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.\n\nYogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch'}], 'classes': [{'categories': [{'measurements': [{'value': '2694', 'spread': '1028', 'groupId': 'OG000'}, {'value': '2537', 'spread': '933', 'groupId': 'OG001'}, {'value': '2317', 'spread': '940', 'groupId': 'OG002'}, {'value': '2335', 'spread': '1051', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2918', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '18', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1000', 'groupDescription': 'A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Four hours or 1.5 hour after consumption of a pre-load at up to day 22', 'description': 'Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.', 'unitOfMeasure': 'kJ', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Energy intake'}, {'type': 'SECONDARY', 'title': 'The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydextrose Syrup Preload With Yogurt With Breakfast [A]', 'description': 'Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch'}, {'id': 'OG001', 'title': 'Glucose Syrup as Proload With Breakfast (Control) [B]', 'description': 'Breakfast with glucose syrup and yogurt provided four hours before lunch.'}, {'id': 'OG002', 'title': 'Pre-load With Polydextrose Before Lunch [C]', 'description': 'Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch'}, {'id': 'OG003', 'title': 'Pre-load With Glucose Syrup Before Lunch [D]', 'description': 'Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.'}], 'classes': [{'title': 'Hunger score', 'categories': [{'measurements': [{'value': '358.3', 'spread': '183.4', 'groupId': 'OG000'}, {'value': '336.8', 'spread': '158.9', 'groupId': 'OG001'}, {'value': '356.7', 'spread': '169.1', 'groupId': 'OG002'}, {'value': '280.2', 'spread': '167.2', 'groupId': 'OG003'}]}]}, {'title': 'Fullness score during first phase', 'categories': [{'measurements': [{'value': '-424.7', 'spread': '192.4', 'groupId': 'OG000'}, {'value': '-443.0', 'spread': '190.7', 'groupId': 'OG001'}, {'value': '-326.6', 'spread': '207.6', 'groupId': 'OG002'}, {'value': '-308.2', 'spread': '155.6', 'groupId': 'OG003'}]}]}, {'title': 'Hunger score (satiety period)', 'categories': [{'measurements': [{'value': '4898.9', 'spread': '3424', 'groupId': 'OG000'}, {'value': '4134.9', 'spread': '2962.9', 'groupId': 'OG001'}, {'value': '962.8', 'spread': '1232.2', 'groupId': 'OG002'}, {'value': '592.9', 'spread': '987.2', 'groupId': 'OG003'}]}]}, {'title': 'Fulness score (satiety period)', 'categories': [{'measurements': [{'value': '-6009.9', 'spread': '3670.8', 'groupId': 'OG000'}, {'value': '-5048.3', 'spread': '4088.4', 'groupId': 'OG001'}, {'value': '-734.8', 'spread': '1263.5', 'groupId': 'OG002'}, {'value': '-1077.4', 'spread': '1118.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0109', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'AUC of hunger scores before preload intake for condition C versus D.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'one day', 'description': 'The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)', 'unitOfMeasure': 'mm*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydextrose Syrup at Breakfast [A]', 'description': 'Breakfast with polydextrose and yogurt provided four hours before lunch.'}, {'id': 'OG001', 'title': 'Glucose Syrup at Breakfast (Control) [B]', 'description': 'Breakfast with glucose syrup and yogurt provided four hours before lunch.'}], 'classes': [{'title': 'CCK (AUC)', 'categories': [{'measurements': [{'value': '241.15', 'spread': '113.69', 'groupId': 'OG000'}, {'value': '265.03', 'spread': '112.44', 'groupId': 'OG001'}]}]}, {'title': 'Ghrelin (AUC)', 'categories': [{'measurements': [{'value': '-23479', 'spread': '33428', 'groupId': 'OG000'}, {'value': '-20902', 'spread': '21150', 'groupId': 'OG001'}]}]}, {'title': 'PYY (AUC)', 'categories': [{'measurements': [{'value': '1745.5', 'spread': '2861.7', 'groupId': 'OG000'}, {'value': '1210.5', 'spread': '2832.6', 'groupId': 'OG001'}]}]}, {'title': 'GLP-1 (AUC)', 'categories': [{'measurements': [{'value': '447.65', 'spread': '298.11', 'groupId': 'OG000'}, {'value': '316.02', 'spread': '244.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0216', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'GLP-1', 'groupDescription': 'A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.', 'description': 'The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.\n\nThe satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).\n\nArea under the curves were calculated of the time curves.', 'unitOfMeasure': '(mcg*min)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only in condition A and B blood was drawn and satiety hormones were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min\n\nEight orders:\n\nA-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Condition A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Condition B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Condition C', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Condition D', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment lasted from May 2014 - August 2014. 121 subjects were planned for screening. 46 subjects met the inclusion criteria, 37 subjects did not show up, and 38 subjects had screening failures.\n\nThe CRO that conducted the clinical trial was:\n\nQPS Netherlands B.V. Groningen The Netherlands', 'preAssignmentDetails': 'In the study four test days were conducted, one weekly. Between test day there are six days of wash-out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Baseline Charactistics of 32 Slightly Overweight Women', 'description': 'Baseline data of the subjects were measured at screening at least one week before the start of the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.70', 'spread': '0.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BPsys', 'classes': [{'categories': [{'measurements': [{'value': '113.5', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Systolic blood pressure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BPdia', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Diastolic blood pressure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dutch Eating Restraintness Score', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Score ranges from 0 - 5 0 = unrestrained 5 = very restrained', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dietary fiber intake', 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Breakfast meal with or without polydextrose'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2014-02-11', 'resultsFirstSubmitDate': '2015-12-24', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-25', 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.', 'timeFrame': 'Four hours or 1.5 hour after consumption of a pre-load at up to day 22', 'description': 'Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.'}], 'secondaryOutcomes': [{'measure': 'The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)', 'timeFrame': 'one day', 'description': 'The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)'}, {'measure': 'Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.', 'timeFrame': 'Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.', 'description': 'The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.\n\nThe satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).\n\nArea under the curves were calculated of the time curves.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pre-load', 'satiety', 'energy intake', 'appetite'], 'conditions': ['Body Weight', 'Non-restrained Eaters']}, 'referencesModule': {'references': [{'pmid': '27916475', 'type': 'DERIVED', 'citation': 'Ibarra A, Olli K, Pasman W, Hendriks H, Alhoniemi E, Raza GS, Herzig KH, Tiihonen K. Effects of polydextrose with breakfast or with a midmorning preload on food intake and other appetite-related parameters in healthy normal-weight and overweight females: An acute, randomized, double-blind, placebo-controlled, and crossover study. Appetite. 2017 Mar 1;110:15-24. doi: 10.1016/j.appet.2016.12.002. Epub 2016 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that regulate satiety may play a role in weight management. Suppression of appetite may reduce energy intake, which in return may lead to body weight reduction. This study aims to verify the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight and overweight women.', 'detailedDescription': 'Polydextrose is a well-tolerated, low calorie glucose polymer (4kJ/g) that can be easily incorporated into various food applications to replace sugar and fat (Auerbach et al., 2007). Polydextrose is poorly digested in the upper gastrointestinal tract and therefore shows fiber-like properties. The addition of polydextrose to foods may increase the satiating properties of foods.\n\nPrevious studies have shown that:\n\n* Consuming polydextrose-containing preloads (6.25 - 25.0 g polydextrose) resulted in a significant lower energy intake at lunch compared to the control (Astbury et al., 2013; Ranawana et al., 2013; Hull et al., 2012; King et al., 2005).\n* Polydextrose is able to modify appetite ratings at low (6.25 - 12.5 g polydextrose) (Hull et al., 2012) and high doses (56.7 g/d) (Konings et al., 2013).\n* Polydextrose (15.0 g) induced enhanced GLP-1 response after a high-fat meal in obese participants (Tiihonen et al., 2012).\n\nTherefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared with the placebo, appetite will be suppressed, resulting in:\n\n* a lower consumption at lunch (energy intake at lunch)\n* change in appetite scores (VAS)\n* change in satiety hormones (CCK, PYY, GLP-1, ghrelin)\n* change in glucose and insulin\n* change in stomach emptying rate\n* change in gastric wellbeing'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy, female participants aged 20-45 years inclusive\n2. BMI: 20-30 kg/m2 inclusive\n3. Written consent regarding participation after full information regarding all details of the study\n4. Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)\n\nExclusion Criteria:\n\n1. Pregnancy\n2. On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product\n3. Reported postmenopausal\n4. Having menstruation problems, e.g. PCOS\n5. Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)\n6. Aversion towards products (yoghurt) provided in the study\n7. On-going use of any slimming preparations\n8. Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis\n9. Restrained eaters (score DEBQ \\>3.4)\n10. Participants consuming more than 23g of dietary fiber per day - P75 according to the Dutch National Food Consumption Survey - (as assessed with a general short questionnaire which gives estimation on the fiber intake. Exact fiber intake will not be calculated)\n11. Smoker in the last 3 months\n12. Heavy coffee drinkers (more than 6 cups a day)\n13. High level of physical activity: Participants who perform more than 3 hours of intense training/sport activity per week (this will not include normal cycling transport)\n14. Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink).\n\nRemark:\n\nWhen enough subjects are eligible (\\> 32), the women with the highest BMI will be selected to participate. At least 50% of the subjects will have a BMI ranging of 25-30. Also at least 50% of the women will be in the age range of 25-45 years. When more than 32 subjects are eligible the eldest subjects will be included.\n\nWith respect to eligibility of the subjects:\n\nthe BMI criterion always comes for age criterion, meaning that overweight is stressed to be of more importance for this study than age. Overweight will always come first, even when already \\> 50% of the women with a BMI 25-30 have been included. In this way the overweight group of women will be studied as much as possible.'}, 'identificationModule': {'nctId': 'NCT02064205', 'briefTitle': 'Appetite Suppression Trial With Polydextrose', 'organization': {'class': 'OTHER', 'fullName': 'TNO'}, 'officialTitle': 'A Double Blind, Placebo Controlled, Randomized, Cross-over Study to Assess the Effects of Polydextrose on Appetite Suppression and Its Mechanisms of Action in Healthy Women With a Normal Weight and Overweight Female Participants.', 'orgStudyIdInfo': {'id': 'JZ PDX Satiety'}, 'secondaryIdInfos': [{'id': 'WM-01-2014', 'type': 'OTHER', 'domain': 'QPS, The Netherlands'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'polydextrose or glucose syrup at breakfast', 'description': 'Breakfast with pre-load four hours before lunch', 'interventionNames': ['Dietary Supplement: 12.5 g polydextrose', 'Dietary Supplement: glucose syrup']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pre-load with yogurt and polydextrose or glucose later', 'description': 'Breakfast without pre-load. Pre-load with yogurt provided 1.5h before lunch.', 'interventionNames': ['Dietary Supplement: 12.5 g polydextrose', 'Dietary Supplement: glucose syrup']}], 'interventions': [{'name': '12.5 g polydextrose', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Litesse®Ultra TM'], 'description': 'Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.', 'armGroupLabels': ['Pre-load with yogurt and polydextrose or glucose later', 'polydextrose or glucose syrup at breakfast']}, {'name': 'glucose syrup', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Glucose syrup is used a control product for the polydextrose', 'armGroupLabels': ['Pre-load with yogurt and polydextrose or glucose later', 'polydextrose or glucose syrup at breakfast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713AG', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'QPS', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Naguib Muhsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QPS, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.J. Pasman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Project Manager Clinical Trials', 'investigatorFullName': 'W.J. Pasman', 'investigatorAffiliation': 'TNO'}}}}