Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT04864769
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D030262', 'term': 'Soybean Proteins'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amino acids concentrations', 'timeFrame': '10 minutes prior to supplement up to 180 minutes after supplement', 'description': 'Measurement of changes in amino acids concentrations in the blood'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '10 minutes prior to supplement up to 180 minutes after supplement', 'description': 'Measurements of changes in Hunger and satiety using 100 mm Visual Analogue Scores'}, {'measure': 'Insulin', 'timeFrame': '10 minutes prior to supplement up to 180 minutes after supplement', 'description': 'Changes in serum insulin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein', 'Amino Acids', 'Krill', 'Whey', 'Soy', 'Satiety', 'Insulin'], 'conditions': ['Human Nutrition']}, 'descriptionModule': {'briefSummary': 'Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate.', 'detailedDescription': 'Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men\n* 18-30 years\n\nExclusion Criteria:\n\n* smoking,\n* medication,\n* health issues conflicting with the experimental trial'}, 'identificationModule': {'nctId': 'NCT04864769', 'acronym': 'KRILL', 'briefTitle': 'Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effect of Intake of Hydrolyzed Krill Protein Isolate, Whey Protein Isolate and Soy Protein Isolate on Plasma Amino Acid Profile', 'orgStudyIdInfo': {'id': 'Krill Protein'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Krill Protein Hydrolysate', 'description': 'Krill Protein Hydrolysate', 'interventionNames': ['Dietary Supplement: Krill protein hydrolysate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soy protein isolate', 'description': 'Soy Protein isolate', 'interventionNames': ['Dietary Supplement: Soy protein isolate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whey protein isolate', 'description': 'Whey protein isolate', 'interventionNames': ['Dietary Supplement: Whey protein isolate']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Water', 'interventionNames': ['Dietary Supplement: Water']}], 'interventions': [{'name': 'Krill protein hydrolysate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 35 g Krill protein hydrolysate', 'armGroupLabels': ['Krill Protein Hydrolysate']}, {'name': 'Soy protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 35 g Soy protein isolate', 'armGroupLabels': ['Soy protein isolate']}, {'name': 'Whey protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 35 g Whey protein isolate', 'armGroupLabels': ['Whey protein isolate']}, {'name': 'Water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of water (control)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University, Department for Public Health, Section for Sport Science', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be available by contacting the corresponding author up to five years after publication. However, before reuse an acceptance from the participants for reuse is mandatory.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mette Hansen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aker BioMarine Human Ingredients AS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mette Hansen', 'investigatorAffiliation': 'University of Aarhus'}}}}