Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06155656
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acid profile in blood', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of amino acid profile in plasma (nmol/ml)'}], 'secondaryOutcomes': [{'measure': 'Parameters of protein metabolism in blood I', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of urea (mg/dL and mol/L) in blood'}, {'measure': 'Parameters of protein metabolism in blood II', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of nitrogen (mg/dL) in blood'}, {'measure': 'Parameters of glucose metabolism in blood I', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of glucose (mg/dL and mmol/L) in blood'}, {'measure': 'Parameters of glucose metabolism in blood II', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of insulin (nmol/L and pmol/L) in blood'}, {'measure': 'Gastric emptying rate', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of gastric emptying rate based on paracetamol kinetics in blood (µg/mL)'}, {'measure': 'Hunger/satiety and acceptance of the meals', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (e.g., 0 = not hungry at all, 10 = very hungry)'}, {'measure': 'Uric acid in blood', 'timeFrame': 'Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of uric acid (mg/dL and mmol/L) in blood'}, {'measure': 'Copper in blood', 'timeFrame': 'Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of copper (µg/l) in blood'}, {'measure': 'Zinc in blood', 'timeFrame': 'Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of zinc (µg/l) in blood'}, {'measure': 'Iron in blood', 'timeFrame': 'Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of iron (µg/l) in blood'}, {'measure': 'Selenium in blood', 'timeFrame': 'Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)', 'description': 'Analysis of selenium (µg/l) in blood'}, {'measure': 'Amino acid profile in urine', 'timeFrame': 'Postprandial period of 5 hours', 'description': 'Analysis of amino acids in urine (nmol/mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postprandial metabolic events'], 'conditions': ['Plasma Amino Acid Appearance and Disappearance', 'Postprandial Metabolic Events']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.', 'detailedDescription': 'In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.\n\nDuring a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* non-smoking\n* metabolically healthy\n* normal weight (BMI: 18,5 - 24,9 kg/m2)\n* written informed consent\n\nExclusion Criteria:\n\n* pregnancy, lactation\n* hypo- or hypertension\n* underweight or overweight/obesity\n* food intolerances and allergies (especially milk protein, pea, celery)\n* malabsorption syndromes\n* gastrointestinal diseases\n* thyroid diseases\n* diabetes mellitus type 1 and type 2\n* impaired kidney or liver function\n* anaemia\n* blood coagulation disorders\n* irregular menstrual cycle\n* endometriosis, severe menstrual problems\n* hormonal contraception\n* regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol)\n* hypersensitivity to paracetamol\n* body weight below 50 kg\n* alcohol abuse\n* glucose-6-phosphate dehydrogenase deficiency\n* Gilbert's syndrome\n* vegan diet\n* eating disorders (especially anorexia nervosa, bulimia nervosa)\n* smoking\n* participation in another study"}, 'identificationModule': {'nctId': 'NCT06155656', 'briefTitle': 'Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Bonn'}, 'officialTitle': 'Acute Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Women and Men', 'orgStudyIdInfo': {'id': 'AlProPlant-HS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pea concentrate', 'description': 'Participants randomized to receive a soup containing 25 g of protein from pea protein concentrate', 'interventionNames': ['Other: Pea protein concentrate']}, {'type': 'EXPERIMENTAL', 'label': 'Pea isolate', 'description': 'Participants randomized to receive a soup containing 25 g of protein from pea protein isolate', 'interventionNames': ['Other: Pea protein isolate']}, {'type': 'EXPERIMENTAL', 'label': 'Pea extrudate', 'description': 'Participants randomized to receive a soup containing 25 g of protein from pea protein extrudate', 'interventionNames': ['Other: Pea protein extrudate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whey', 'description': 'Participants randomized to receive a soup containing 25 g of protein from whey protein', 'interventionNames': ['Other: Whey protein']}], 'interventions': [{'name': 'Pea protein concentrate', 'type': 'OTHER', 'description': 'Ingestion of a soup containing 25 g of protein from pea protein concentrate', 'armGroupLabels': ['Pea concentrate']}, {'name': 'Pea protein isolate', 'type': 'OTHER', 'description': 'Ingestion of a soup containing 25 g of protein from pea protein isolate', 'armGroupLabels': ['Pea isolate']}, {'name': 'Pea protein extrudate', 'type': 'OTHER', 'description': 'Ingestion of a soup containing 25 g of protein from pea protein extrudate', 'armGroupLabels': ['Pea extrudate']}, {'name': 'Whey protein', 'type': 'OTHER', 'description': 'Ingestion of a soup containing 25 g of protein from whey protein', 'armGroupLabels': ['Whey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53115', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}], 'overallOfficials': [{'name': 'Sarah Egert, Prof PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germany University of Bonn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'University of Bonn, Department of Nutrition and Food Sciences, Food Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sarah Egert, Prof PhD', 'investigatorFullName': 'Prof. Dr. Sarah Egert', 'investigatorAffiliation': 'University of Bonn'}}}}