Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-06 @ 10:32 AM
Study NCT ID:
NCT02347293
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
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': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose, levels of glucose in blood', 'timeFrame': 'Postprandial 0-180 min after breakfast'}, {'measure': 'Insulin, levels of insulin in blood', 'timeFrame': 'Postprandial 0-180 min after breakfast'}, {'measure': 'Appetite hormones, levels of Peptide YY (PYY) in blood', 'timeFrame': 'Postprandial 0-180 min after breakfast'}, {'measure': 'Markers of colonic fermentation, levels of hydrogen in breath', 'timeFrame': 'Postprandial 0-180 min after breakfast'}, {'measure': 'Inflammation markers, levels of Interleukin-6 (IL-6) in blood', 'timeFrame': 'Postprandial 0-180 min after breakfast'}], 'secondaryOutcomes': [{'measure': 'Subjective satiety, as measured by VAS', 'timeFrame': 'Postprandial 0-180 min after breakfast'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '29338758', 'type': 'DERIVED', 'citation': 'Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.'}, {'pmid': '28431559', 'type': 'DERIVED', 'citation': 'Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.'}]}, 'descriptionModule': {'briefSummary': 'The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal fasting blood glucose\n* BMI 19-25 kg/m2\n\nExclusion Criteria:\n\n* Gastrointestinal diseases\n* Food allergies e.g. lactose-, gluten intolerance\n* Metabolic disorder e.g. diabetes\n* Tobacco/snuff users\n* No antibiotic or probiotic intake 2 weeks prior and during study.\n* Vegetarians'}, 'identificationModule': {'nctId': 'NCT02347293', 'briefTitle': 'Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety', 'orgStudyIdInfo': {'id': 'Dnr2013/241b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '+ ind. CHO', 'description': 'Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables', 'interventionNames': ['Other: High levels of indigestible carbohydrates']}, {'type': 'EXPERIMENTAL', 'label': '- ind. CHO', 'description': 'Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables', 'interventionNames': ['Other: Low levels of indigestible carbohydrates']}], 'interventions': [{'name': 'High levels of indigestible carbohydrates', 'type': 'OTHER', 'armGroupLabels': ['+ ind. CHO']}, {'name': 'Low levels of indigestible carbohydrates', 'type': 'OTHER', 'armGroupLabels': ['- ind. CHO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Medicon Village', '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, postgraduate student', 'investigatorFullName': 'Jonna Sandberg', 'investigatorAffiliation': 'Lund University'}}}}