Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-09 @ 9:55 AM
Study NCT ID:
NCT03648112
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL cholesterol', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]', 'description': 'LDL cholesterol \\[mmol/L\\]'}], 'secondaryOutcomes': [{'measure': 'total cholesterol', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]', 'description': 'total cholesterol \\[mmol/L\\]'}, {'measure': 'HDL cholesterol', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]', 'description': 'HDL cholesterol \\[mmol/L\\]'}, {'measure': 'triacylglycerides', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]', 'description': 'triacylglycerides \\[mmol/L\\]'}, {'measure': 'HOMA-index', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'HOMA-index'}, {'measure': 'fasting blood glucose', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'fasting blood glucose \\[mg/dl\\]'}, {'measure': 'kinetic of glycemic answer', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'blood glucose (mg/dl; timepoints: 0, 30, 60, 120 and 180 min) after a test meal)'}, {'measure': 'kinetic of satiety hormones', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'Ghrelin, GLP1, peptide YY (timepoints: 0, 30, 60, 120 and 180 min) after a test meal)'}, {'measure': 'short chain fatty acids in fecal water', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'short chain fatty acids (SCFA; %) , pH value, composition of microbiome'}, {'measure': 'composition of microbiome', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'composition of microbiome \\[%\\]'}, {'measure': 'blood pressure', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'systolic and diastolic blood pressure \\[mmHg\\]'}, {'measure': 'height', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'Height \\[m\\]'}, {'measure': 'weight', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'Weight \\[kg\\]'}, {'measure': 'body-mass index', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'body-mass index \\[kg/m2\\]'}, {'measure': 'bioelectrical impedance analysis', 'timeFrame': '[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]', 'description': 'bioelectrical impedance analysis (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dietary fibres', 'ß-glucan', 'low-density-lipoprotein-cholesterol', 'insulin', 'fasting glucose', 'microbiota'], 'conditions': ['Lipid Metabolism', 'Glucose Metabolism', 'Satiety']}, 'referencesModule': {'references': [{'pmid': '36819683', 'type': 'DERIVED', 'citation': 'Reiners S, Hebestreit S, Wedekind L, Kiehntopf M, Klink A, Rummler S, Glei M, Lorkowski S, Schlormann W, Dawczynski C. Effect of a regular consumption of traditional and roasted oat and barley flakes on blood lipids and glucose metabolism-A randomized crossover trial. Front Nutr. 2023 Feb 2;10:1095245. doi: 10.3389/fnut.2023.1095245. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fnut.2023.1095245/full', 'label': 'Study results'}]}, 'descriptionModule': {'briefSummary': 'The interventional study will evaluate the effects of a regularly consumption of barley and oat flakes in crude and roasted form on the glucose and lipid metabolism as well as the postprandial saturation. Moreover, the study will evaluate the effect of a regularly consumption of barley and oat flakes on the glucose and lipid metabolism over a period of three weeks.\n\nAll participants will run through each intervention (cross-over design). Inbetween these intervention periods there will be wash-out phases. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. The comparison will be made against white toastbread. The study participants will visit the study centrum before and after each intervention over an entire period of 27 weeks.', 'detailedDescription': 'The interventional study will evaluate the effects of a regularly consumption of barley and oat flakes in crude and roasted form on the glucose and lipid metabolism as well as the postprandial saturation. Moreover, the study will evaluate the effect of a regularly consumption of barley and oat flakes on the glucose and lipid metabolism over a period of three weeks.\n\nBy applying the cross-over design, all participants will run through each intervention. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. Each intervention period will last three weeks and will be separated by wash-out phases which also will last three weeks. The comparison will be made against white toastbread, which will be the fifth intervention. The entire duration of the study will be 27 weeks (5x 3 weeks intervention + 4x 3 weeks wash-out phases inbetween).\n\nThe participants will visit the study centrum before and after each intervention for examinations and for taking blood samples. During the examination the participants will receive a test-meal to evaluate postprandial blood glucose and insulin levels. Moreover, the kinetic of hormones that influence the satiety will be evaluated. In addition to the examination of blood samples, the microbiota of feces will be examined.\n\nDuring the intervention periods the participants will receive recipes for breakfast for 21 days. In these recipes 80 gram oat or barley flakes or four slices of white toastbread will be included.\n\nThe study will provide data about the association between different processed cereals and measurable markers reflecting glucose and lipid metabolism as well as their influence on hormones of satiety and microbiota.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)\n* Typical western diet\n\nExclusion Criteria:\n\n* intake of lipid-lowering medications\n* gastrointestinal diseases\n* diabetes mellitus type I and II\n* familial hypercholesterolemia\n* intake of additional dietary supplements (especially ß-glucan capsules, high-fibre compounds)\n* pregnancy, lactation\n* appreciable food allergies/intolerances\n* patient´s request or if patient compliance with the study protocol is doubtful'}, 'identificationModule': {'nctId': 'NCT03648112', 'acronym': 'gLUCAn', 'briefTitle': 'Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Intervention Study - Physiological Short-term and Long-term Effects of Regularly Consumption of Beta-glucan From Barley and Oats on the Glucose and Lipid Metabolism and Satiety', 'orgStudyIdInfo': {'id': 'H7_18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention 1', 'description': 'Intervention 1: Crude oat flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes.', 'interventionNames': ['Dietary Supplement: Intervention 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention 2', 'description': 'Roasted oat flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients.\n\nThese oat flakes were roasted at 150°C for 20 minutes.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes.', 'interventionNames': ['Dietary Supplement: Intervention 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention 3', 'description': 'Crude barley flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes', 'interventionNames': ['Dietary Supplement: Intervention 3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention 4', 'description': 'Roasted barley flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes.', 'interventionNames': ['Dietary Supplement: Intervention 4']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Intervention 1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Crude oat flakes'], 'description': 'The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.', 'armGroupLabels': ['Intervention 1']}, {'name': 'Intervention 2', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Roasted oat flakes'], 'description': 'The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.', 'armGroupLabels': ['Intervention 2']}, {'name': 'Intervention 3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Crude barley flakes'], 'description': 'The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.', 'armGroupLabels': ['Intervention 3']}, {'name': 'Intervention 4', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Roasted barley flakes'], 'description': 'The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.', 'armGroupLabels': ['Intervention 4']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['White toast bread'], 'description': 'White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread.\n\nThe study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich-Schiller-University', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Christine Dawczynski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jena'}, {'name': 'Stefan Lorkowski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Leader of the Junior Research Group Nutritional Concepts', 'investigatorFullName': 'Christine Dawczynski,PhD', 'investigatorAffiliation': 'University of Jena'}}}}