Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-14 @ 11:15 AM
Study NCT ID:
NCT01905956
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2013-07-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pwchong@inqpharm.com', 'phone': '+603 6201 9690', 'title': 'Pee-Win Chong', 'phoneExt': '358', 'organization': 'InQpharm Europe Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the treatment period ie. 12 weeks.', 'description': 'The causality of the AEs and intake of IP was assessed by the clinician.\n\nThree subjects who were excluded (due to violation of inclusion/exclusion criteria, and treatment compliance) in the Intention-to-treat population were included in the adverse events analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102', 'otherNumAtRisk': 58, 'otherNumAffected': 12, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo', 'otherNumAtRisk': 56, 'otherNumAffected': 12, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Common cold or upper respiratory tract infection', 'notes': 'Light to moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache or dental extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal complaints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches and Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Distortion and contusion of knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abcess of the skin', 'notes': 'In the breastbone area', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Sciatica (Dorsalgia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection of urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea & Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Prostate Cancer', 'notes': 'Improbable relation to Investigational product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Body Weight From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values).', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Waist Circumference', 'categories': [{'measurements': [{'value': '2.12', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '3.24', 'groupId': 'OG001'}]}]}, {'title': 'Hip Circumference', 'categories': [{'measurements': [{'value': '2.25', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.\n\nHip circumference (cm) was measured as the maximal circumference over the buttocks.\n\nResults were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values).', 'unitOfMeasure': 'centimetre (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Body Fat Content (%) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values).', 'unitOfMeasure': 'Percentage of body fat (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Body Fat Mass (kg) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values).', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.'}, {'type': 'SECONDARY', 'title': 'Food Craving Questionnaire (FCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.65', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.31', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4, 8, and 12 weeks', 'description': 'This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:\n\n1. = I do not agree at all\n2. = I do not agree\n3. = Neutral\n4. = I agree\n5. = I highly agree\n\nResults were expressed as the mean score for the whole population in the respective intervention group.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.'}, {'type': 'SECONDARY', 'title': 'Global Evaluation of Efficacy by the Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.'}, {'type': 'SECONDARY', 'title': 'Global Evaluation of Efficacy by the Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.'}, {'type': 'SECONDARY', 'title': 'Global Evaluation of Safety by the Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.'}, {'type': 'SECONDARY', 'title': 'Global Evaluation of Safety by the Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Intention-to-treat Population', 'achievements': [{'comment': 'Intention-to-treat population', 'groupId': 'FG000', 'numSubjects': '57'}, {'comment': 'Intention-to-treat population', 'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Per-protocol population', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'Per-protocol population', 'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily\n\nIQP-AK-102'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 capsules per dose, 3 times daily\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '46.3', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.3', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '168.2', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '168.8', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimetres (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.0', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '80.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '81.9', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per metre square (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '102.1', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '98.5', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '100.4', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimetres (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hip Circumference', 'classes': [{'categories': [{'measurements': [{'value': '110.2', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '108.7', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '109.5', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimetres (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '123.9', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '128.1', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '125.9', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '79.7', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '81.3', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '80.5', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '70.6', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2013-07-19', 'resultsFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-10', 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Body Weight From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values).'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.\n\nHip circumference (cm) was measured as the maximal circumference over the buttocks.\n\nResults were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values).'}, {'measure': 'Mean Change in Body Fat Content (%) From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values).'}, {'measure': 'Mean Change in Body Fat Mass (kg) From Baseline to Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).\n\nResults were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values).'}, {'measure': 'Food Craving Questionnaire (FCQ)', 'timeFrame': 'Baseline and 4, 8, and 12 weeks', 'description': 'This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:\n\n1. = I do not agree at all\n2. = I do not agree\n3. = Neutral\n4. = I agree\n5. = I highly agree\n\nResults were expressed as the mean score for the whole population in the respective intervention group.'}, {'measure': 'Global Evaluation of Efficacy by the Investigators', 'timeFrame': '12 weeks'}, {'measure': 'Global Evaluation of Efficacy by the Subjects', 'timeFrame': '12 weeks'}, {'measure': 'Global Evaluation of Safety by the Investigators', 'timeFrame': '12 weeks'}, {'measure': 'Global Evaluation of Safety by the Subjects', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation.', 'detailedDescription': 'Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by biological, behavioral and environmental stimuli. Satiation (intrameal satiety) is defined as the process of feeling full and subsequently stopping food consumption during eating, it therefore reduces hunger and limits the energy consumptions during meals. On the other hand, satiety or more precisely intermeal satiety, delays the onset and possibly reduces the consumption of the next meal. High viscosity and bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than macronutrients or clear liquid.\n\nDue to its unique physicochemical properties, dietary fibre has been recognized as a potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake, and eventually leading on to weight loss.\n\nThe investigational product is formulated from IQP-AK-102, a proprietary, patent pending combination of three soluble fibres. In-vitro studies showed synergistic properties for the fibres in IQP-AK-102. When consumed orally, IQP-AK-102 capsules dissolve in the stomach to release the fibres. Once hydrated, the fibres swell to form a thick, viscous and indigestible gel structure in the stomach. This physical structure results in increased gastric distension and delays the gastric emptying that induces satiety and fullness.\n\nHowever the unique composition of IQP-AK-102 had not been evaluated in human clinical studies. The objective of this placebo controlled, double blind study was to confirm the benefit of IQP-AK-102 in weight loss through promoting satiety and managing appetite. In this study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if IQP-AK-102 is effective in reducing body weight over a period of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 65 years\n* 25≤BMI≤35\n* Expressed desire for weight loss\n* Accustomed to 3 main meals/day\n* Generally in good health\n* Consistent and stable body weight 3 months prior to study enrolment\n* Consistent regular physical activity\n* Commitment to avoid the use of other weight loss products during study\n* Commitment to adhere to diet and lifestyle recommended for the study\n\nExclusion Criteria:\n\n* Known sensitivity to the ingredients of the device\n* Presence of any active gastrointestinal disease\n* Malabsorption disorders\n* Pancreatitis\n* Stenosis in the GI tract\n* Bariatric surgery\n* Any other reason deemed suitable for exclusion, per investigator's judgement"}, 'identificationModule': {'nctId': 'NCT01905956', 'briefTitle': 'Safety and Efficacy of IQP- AK-102 in Reducing Body Weight', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of IQP- AK-102 in Reducing Body Weight in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': 'INQ/010013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IQP-AK-102', 'description': '2 capsules per dose, three times daily', 'interventionNames': ['Dietary Supplement: IQP-AK-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 capsules per dose, 3 times daily', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'IQP-AK-102', 'type': 'DIETARY_SUPPLEMENT', 'description': 'IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.', 'armGroupLabels': ['IQP-AK-102']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10709', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Barbara Grube', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Udo Bongartz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'analyze & realize GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}