Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-10 @ 1:07 AM
Study NCT ID:
NCT03806920
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'participants were unaware of selected sugar intake prior to second meal'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disposition index', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)'}, {'measure': 'insulinogenic index', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).'}, {'measure': 'hepatic insulin extraction', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).'}], 'secondaryOutcomes': [{'measure': 'incretin response', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Parameters: GIP, GLP-1, gastric emptying, Glucagon'}, {'measure': 'inflammatory reaction', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Parameters: IL8, IL-18'}, {'measure': 'Lipid status', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Parameters: NEFA'}, {'measure': 'additional endocrine parameters', 'timeFrame': '4 visits, separated by 1 week each', 'description': 'Parameters: FGF21'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isomaltulose', 'Palatinose', 'second meal effect', 'incretin', 'GIP', 'GLP-1', 'postprandial inflammation'], 'conditions': ['Diabetes Mellitus, Type 2', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '36857956', 'type': 'DERIVED', 'citation': 'Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.\n\nIn this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.', 'detailedDescription': 'Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.\n\nIn summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.\n\nIn this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for T2DM patients: insulin-independent\n* for healthy subjects: at least 1 component of the metabolic syndrom:\n\n * Body mass index (BMI) ≥ 30 kg/m²\n * Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men\n * hypertension\n * dyslipidemia\n * glucose / insulin intolerance\n\nExclusion Criteria:\n\n* medications: intake of medications which influence glucose metabolism\n* alcohol / drug abuse\n* physical diseases: endocrinological, malign, serious cardiovascular diseases\n* acute / chronic communicable disease\n* psychic diseases'}, 'identificationModule': {'nctId': 'NCT03806920', 'briefTitle': 'Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect', 'organization': {'class': 'OTHER', 'fullName': 'German Institute of Human Nutrition'}, 'officialTitle': 'Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect', 'orgStudyIdInfo': {'id': 'PALA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention A', 'description': 'Nutritional intervention in healthy subjects and T2DM subjects:\n\nAccompanying a carbohydrate based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.', 'interventionNames': ['Dietary Supplement: Intervention A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention B', 'description': 'Nutritional intervention in healthy subjects and T2DM subjects:\n\nAccompanying a carbohydrate based breakfast, participants ingest either 50 g palatinose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.', 'interventionNames': ['Dietary Supplement: Intervention B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention C', 'description': 'Nutritional intervention in healthy subjects:\n\nAccompanying a protein-based breakfast, participants ingest either 50 g sucrose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.', 'interventionNames': ['Dietary Supplement: Intervention C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention D', 'description': 'Nutritional intervention in healthy subjects:\n\nAccompanying a protein-based breakfast, participants ingest either 50 g isomaltulose followed by a standardized lunch on 1 single day. In addition, blood samples are taken over 8 hours.', 'interventionNames': ['Dietary Supplement: Intervention D']}], 'interventions': [{'name': 'Intervention A', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Intervention A']}, {'name': 'Intervention B', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Intervention B']}, {'name': 'Intervention C', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Intervention C']}, {'name': 'Intervention D', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Intervention D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14458', 'city': 'Potsdam', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'German Institute of Human Nutrition', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Institute of Human Nutrition', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beneo GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director (Dpt. Clinical Nutrition)', 'investigatorFullName': 'Prof. Dr. med. Andreas F. H. Pfeiffer', 'investigatorAffiliation': 'German Institute of Human Nutrition'}}}}