Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT01718418
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-07', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.', 'timeFrame': 'Post-prandially after breakfast, 0-210 min', 'description': 'Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.'}], 'secondaryOutcomes': [{'measure': 'voluntary energy intake', 'timeFrame': 'Post-prandially after breakfast, 0-210 min', 'description': 'Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.'}, {'measure': 'Subjective satiety', 'timeFrame': 'post-prandially after breakfast, 0-210 min', 'description': 'The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.'}, {'measure': 'Differences in gut microbiota', 'timeFrame': 'Faecal samples are collected after 14 days intake of test- and reference product', 'description': 'The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '28531784', 'type': 'DERIVED', 'citation': 'Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives\n\nExclusion Criteria:\n\n* gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians'}, 'identificationModule': {'nctId': 'NCT01718418', 'briefTitle': 'Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety', 'orgStudyIdInfo': {'id': 'Dnr2010/457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '+ ind.CHO + prebiotics', 'description': 'test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.', 'interventionNames': ['Other: test meal']}, {'type': 'EXPERIMENTAL', 'label': '+ ind.CHO - prebiotics', 'description': 'test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.', 'interventionNames': ['Other: test meal']}, {'type': 'EXPERIMENTAL', 'label': '- ind.CHO - prebiotics', 'description': 'reference: no ind. carbohydrates and no probiotic supplement', 'interventionNames': ['Other: reference']}], 'interventions': [{'name': 'test meal', 'type': 'OTHER', 'armGroupLabels': ['+ ind.CHO + prebiotics', '+ ind.CHO - prebiotics']}, {'name': 'reference', 'type': 'OTHER', 'armGroupLabels': ['- ind.CHO - prebiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 00', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Applied Nutrition and Food Chemistry, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Anne Nilsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, post-graduate student', 'investigatorFullName': 'Elin Johansson', 'investigatorAffiliation': 'Lund University'}}}}