Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-27 @ 2:26 PM
Study NCT ID:
NCT06465004
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Trial: Bioavailability Animal vs. Plant Protein Drink
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-22', 'size': 599310, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-13T04:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leucine content in the blood', 'timeFrame': '4 hours', 'description': 'Assessment of leucine content in blood before and 30-60-90 min after consumption of drink'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leucin', 'Plant-based', 'Animal-based', 'Bioavailability'], 'conditions': ['Nutrition, Healthy', 'Leucine Sensitivity']}, 'descriptionModule': {'briefSummary': 'A pilot study is being conducted to compare a new plant-based protein drink to commercially available animal-based protein drinks. The goal is to assess if the plant-based drink delivers amino acids to the bloodstream as effectively as the animal-based drinks, potentially offering a viable option for those on plant-based diets.\n\nThe study will involve approximately 12 healthy adults aged 18-40. Each participant will try all three drinks (the new plant-based drink, a commercial animal-based drink, and another animal-based recipe) on separate days in a randomized order. Before and after (30, 60, and 90 minutes) consuming each drink, a small blood sample will be drawn to measure amino acid levels (leucine).\n\nBy comparing the results, the investigators hope to determine if the plant-based drink can match the effectiveness of animal-based protein drinks in delivering essential nutrients. This research could contribute to the development of sustainable and nutritious plant-based protein alternatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Gender: male and female\n* Age: 18-40 years\n* Signed written informed consent\n\nExclusion criteria\n\n* Smoking history\n* Cardiovascular diseases\n* BMI \\> 35 kg/m2\n* Caffeine consumption \\< 1 day before the study participation\n* Allergies: Soy, Peas, Milk, Lactose, Fructose\n* High intensity exercise \\<2 days before study participation'}, 'identificationModule': {'nctId': 'NCT06465004', 'briefTitle': 'Pilot Trial: Bioavailability Animal vs. Plant Protein Drink', 'organization': {'class': 'OTHER', 'fullName': 'ETH Zurich'}, 'officialTitle': 'Exploratory Pilot Trial Assessing the Immediate Impact of Animal-based and Plant-based Protein Drinks on Blood Parameters', 'orgStudyIdInfo': {'id': '2024-00151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Animal-based A', 'description': 'A commercially available high protein drink, based on animal proteins (Fresubin Protein Energy)', 'interventionNames': ['Dietary Supplement: Consumption of protein - rich drink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Animal-based B', 'description': 'A homemade drink containing animal-based proteins, using a specific animal-based protein isolate mix.', 'interventionNames': ['Dietary Supplement: Consumption of protein - rich drink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plant-based A', 'description': 'A homemade drink containing plant-based proteins, formulated to have the same macronutrient content as the animal-based drinks.', 'interventionNames': ['Dietary Supplement: Consumption of protein - rich drink']}], 'interventions': [{'name': 'Consumption of protein - rich drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants will drink on of three protein - rich drinks', 'armGroupLabels': ['Animal-based A', 'Animal-based B', 'Plant-based A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8603', 'city': 'Schwerzenbach', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Katrien De Bock, PhD', 'role': 'CONTACT', 'email': 'katrien-debock@ethz.ch'}], 'facility': 'SLA - ETH Zurich', 'geoPoint': {'lat': 47.38213, 'lon': 8.65727}}], 'centralContacts': [{'name': "Gommaar D'Hulst, PhD", 'role': 'CONTACT', 'email': 'gommaar-dhulst@ethz.ch', 'phone': '+41786624474'}], 'overallOfficials': [{'name': "Gommaar D'Hulst, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETH Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}