Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT06170905
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Whey Protein Pre-load and Postprandial Glycemia in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.'}, {'measure': 'Postprandial glucose excursion', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.'}], 'secondaryOutcomes': [{'measure': 'Insulin course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'C-peptide course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'Insulin secretion', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'Glucagon course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'GLP-1 course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'GIP course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.'}, {'measure': 'Glicentin course', 'timeFrame': 'Timepoint 0-120 minutes during the oral glucose tolerance test.', 'description': 'Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postprandial glucose excursions', 'glycemia', 'whey protein', 'protein pre-load', 'pregnancy', 'gestational diabetes mellitus', 'insulin secretion', 'incretins'], 'conditions': ['Pregnancy', 'Postprandial Glycemia']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.', 'detailedDescription': 'Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation\n* BMI before pregnancy: 18 - 29.9 kg/m2\n* No known underlying diseases\n* Understanding and voluntary signing of a consent form before study-related examinations\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Diabetes mellitus type 1 or type 2\n* Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.\n* Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)\n* Current depression or other mental illnesses\n* Eating disorder\n* Regular intake of medication other than vitamins/trace elements during pregnancy\n* Estimated glomerular filtration rate (eGFR) \\< 60 ml/min/1.73 m²\n* C-reactive protein \\> 10 mg/l\n* Transaminase elevation of 2 times the upper norm\n* Pre-existing cardiac diseases\n* Drug and/or alcohol abuse\n* Hb \\< 12 g/dl\n* No consent to be informed about incidentally discovered pathological findings\n* Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.'}, 'identificationModule': {'nctId': 'NCT06170905', 'acronym': 'ProGs', 'briefTitle': 'Whey Protein Pre-load and Postprandial Glycemia in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women', 'orgStudyIdInfo': {'id': '78/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral glucose tolerance test with whey protein pre-load', 'description': '30 minutes prior to the 75 g OGTT, a whey protein solution is given.', 'interventionNames': ['Dietary Supplement: Whey protein-preload OGTT']}, {'type': 'NO_INTERVENTION', 'label': 'Control oral glucose tolerance', 'description': '75 g OGTT without whey protein pre-load.'}], 'interventions': [{'name': 'Whey protein-preload OGTT', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test', 'armGroupLabels': ['Oral glucose tolerance test with whey protein pre-load']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universityhospital Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Martin martin.heni@uniklinik-ulm.de, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Martin Heni', 'investigatorFullName': 'Martin Heni', 'investigatorAffiliation': 'University of Ulm'}}}}