Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04866927
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of Proteins From Plant Based Diets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Amino Acid Digestibility', 'timeFrame': 'One year', 'description': 'The digestibility of each IAA from the 13C-labeled spirulina protein and TCF is an IAA-specific term used to correct for loss of a 2H atom during transamination.'}, {'measure': 'DIAAS', 'timeFrame': 'One year', 'description': 'The digestible indispensable amino acid score (DIAAS), representing the content of each IAA, along with the digestibility of each IAA, in relation to the human requirement pattern was also calculated.'}], 'secondaryOutcomes': [{'measure': 'Scientific articles', 'timeFrame': 'By the end of 2020', 'description': 'Publication of scientific reports and peer-reviewed papers and conference presentations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proteins', 'Digestibility', 'Bioavailability', 'Indispensable Amino Acids', 'Plant-based food', 'Plant diet', 'Nutrition', 'Food security', 'Fava Bean', 'Vegetal proteins'], 'conditions': ['Protein Malabsorption', 'Nutritional Deficiency', 'Nutritional Stunting']}, 'referencesModule': {'references': [{'pmid': '36894238', 'type': 'DERIVED', 'citation': 'Khayour M, Benmhimdane A, Calvez J, Saeid N, Khodorova N, Belghiti H, El Hamdouchi A, El Kari K, Owino V, Tome D, Aguenaou H, Mentag R, El Mzibri M, Gaudichon C. Indispensable Amino Acid Digestibility of Moroccan Fava Bean Using the Dual Isotope Method in Healthy Adults. J Nutr. 2023 Feb;153(2):451-458. doi: 10.1016/j.tjnut.2022.11.015. Epub 2022 Dec 24.'}]}, 'descriptionModule': {'briefSummary': "Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Dietary protein deficiency is mainly due to protein indigestibility limiting indispensable amino acids (IAAs) bioavailability. In Morocco, as it's the case in many developing countries, diet is mainly based on a large consumption of cereals, fruits, vegetables and pulses, and is generally low in meat, which is the main source of protein and IAA.\n\nThe general objective of this study is to evaluate the digestibility of Fava bean proteins and bioavailability of IAA using a dual-tracer method with stable isotopes.", 'detailedDescription': 'This study aims to develop stable isotope labeled protein of bean cultures that could be used for other local common foods, to quantify dietary indispensable amino acids from beans made available to the body for optimal growth, development and function and to participate in the development of a simple method to assess protein quality in vulnerable populations.\n\nThe project is divided in two parts: the first part of harvesting and production of deuterium labeled fava beans. The optimization test done the first year has shown that the best protocol for labelling was a pulse with 25% D2O followed with subsequent labeling with 2.5% D2O during 20 days.\n\nThe second part is the intervention stuy that is going to be conducted on 6 healthy volunteers (3 males, 3 females). Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy individuals who fit in the inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy, non-pregnant adults 18-65 years of age\n\nNot taking any medication, including NSAIDs Not taking antibiotics within 4 weeks of study BMI within 18-35 range Stable weight\n\nExclusion Criteria:\n\nChildren and elderly (over 65)\n\nPregnancy Diagnosed with non-communicable or communicable disease Being under restrictive diet Antibiotics within 4 weeks of study Medications within 4 weeks of study'}, 'identificationModule': {'nctId': 'NCT04866927', 'briefTitle': 'Bioavailability of Proteins From Plant Based Diets', 'organization': {'class': 'OTHER_GOV', 'fullName': 'International Atomic Energy Agency'}, 'officialTitle': 'Use of Stable Isotopic Dilution to Assess Protein Digestibility From Fava Bean and to Evaluate Amino Acid Bioavailability', 'orgStudyIdInfo': {'id': 'E43031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults', 'description': 'Inclusion criteria: Healthy, non-pregnant women, adults aged 18-65 years, not taking any medication, including NSAIDs, not taking antibiotics within 4 weeks of study, BMI within 18-35 range.\n\nExclusion criteria: Children and elderly (over 65), pregnant women, individuals diagnosed with non-communicable or communicable disease, being under restrictive diet, antibiotics within 4 weeks of study, medications within 4 weeks of study.', 'interventionNames': ['Dietary Supplement: Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability']}], 'interventions': [{'name': 'Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.', 'armGroupLabels': ['Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Rabat', 'country': 'Morocco', 'facility': 'Joint Research Unit in Nutrition and Food', 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}], 'overallOfficials': [{'name': 'Mohammed El Mzibri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of the Division of Life Sciences - CNESTEN'}, {'name': 'Hassan Aguenaou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Nutrition RDC of Morocco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Atomic Energy Agency', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'AgroParisTech', 'class': 'OTHER'}, {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, {'name': "Centre National De L'énergie, Des Sciences Et Techniques Nucléaires", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Khayour Meriam', 'investigatorAffiliation': 'International Atomic Energy Agency'}}}}