Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03413267
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Food Structure on Micronutrient Bioavailability in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C034849', 'term': 'BAG 0177'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Because the food matrices ingested by the volunteers have different aspects, no masking is really possible. However, blood samples will be analyzed by partners without knowledge of the matrix that has been ingested.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Bioavailability protocol : each volunteer participates in 4 interventions (4 food matrices), during 4 different days (one food matrix per day). At least 3 weeks between each intervention day. An intervention consists in food matrix ingestion (t=0) and blood sampling for 8 h postprandial (10 sampling times).\n\nMastication protocol : each volunteer participates in 1 session during which 2 solid matrices will be studied. For each matrix, 13 samples are proposed to the volunteer; food bolus are collected just before the volunteer feels the need of swallowing.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative analysis of vitamin D, B9, B12 and lutein in blood', 'timeFrame': '8 hours', 'description': 'Blood sampling before (T-30min to determine basal concentrations) and after food matrix ingestion (T0) for 8 h postprandial (10 sampling between 30 and 480min postprandial) for vitamin D, B9, B12 and lutein measurement in plasma; vitamin D and lutein will be quantified by HPLC-DAD in the chylomicron fraction; vitamin B9 and B12 will be quantified by ELISA method'}, {'measure': 'Quantitative analysis of vitamin B9 and B12 in the liquid fraction of food boluses and characterization of these boluses', 'timeFrame': 'one and half hour', 'description': 'Normal mastication of food matrix and splitting out for characterization of food bolus: granulometry, rheology and vitamin B9 and B12 release in the liquid fraction (saliva + food water + rinsing water); each volunteer successively masticates 13 samples of each solid food matrix (biscuit and sponge cake); vitamin B9 and B12 will be quantified by ELISA method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['micronutrient', 'bioavailability', 'bioaccessibility', 'food structure', 'food texture'], 'conditions': ['Food Structure Impact on Micronutrient Bioavailability']}, 'descriptionModule': {'briefSummary': 'The nutritional quality of foods strongly depends on the structure / texture of foods, because of the impact on food disintegration, and then on digestion process and nutrient utilization by the human body. However, this relationship between food structure and nutrient bioavailability is still widely unknown.\n\nMicroNut project aims at demonstrating and evaluating in humans the impact of structure / texture changes on micronutrient bioavailability. In order to do this, four complex food matrices, with constant composition but different structures / textures, and as close as possible to real foods have been designed and are evaluated in the present study. A mixture of egg and plant proteins is the basis of these lipoprotein matrices in which four micronutrients will be followed up : two lipophilic (vitamin D and lutein) and 2 hydrophilic (vitamins B9 and B12).', 'detailedDescription': 'The main objective consists in understanding how food structure / texture impacts on micronutrient bioavailability. The second objective consists in studying food disintegration at oral phase (in the mouth) and the consequences on the bioaccessibility of hydrophilic vitamins in saliva.\n\nThe clinical study is open, monocentric, controled and randomized, in a cross experimental design.\n\nThe included volunteers (n=12) will participate in the whole two protocols. The first protocol is related to the study of vitamins B9, B12, D and lutein bioavailability during 8h kinetics, after ingestion of a food matrix (custard, biscuit, flan or sponge cake). The second protocol is related to the study of hydrophilic vitamin release during mastication of two of these matrices (biscuit and sponge cake).\n\nThe study is not performed in a double blind way. However, the measure bias will be limited because of the standardized and objective characteristic of the main criteria. Moreover, biological samples will be analysed by the same partners of the project. Each subject will be his own control, so that confusion factors related to individual variability will be eliminated.\n\nThe monocentric characteristic of the study, the low number of subjects and the expertise of the involved staff will enable to limit the number of missing data.\n\nThe randomization (latin square) has been established by a bio-statistician of the project before the study started. A document describing the randomization proceeding is confidentially kept.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no smoking since 6 months at least\n* no pathology and no medical treatment\n* no history of calcium lithiasis\n* BMI \\>=20 and \\<=30 kg/m²\n* normal biological status\n* no dislike for the food tested\n* good dental health, no pain, no treatment in progress, no orthodontics since 3 years\n\nExclusion Criteria:\n\n* hypercalcemia (\\>2.52 mmol/L), hyperphosphoremia (\\>1.58 mmol/L)\n* known pathology\n* allergy or intolerance to one of the food matrix components (egg, vitamins B12, B9, D, lutein, pea, gluten)\n* intake of food supplements and/or UVdose for the 3 months before the study, except enriched foods\n* exposure to UV during the 2 weeks before the study and all along the study\n* vitamin D \\< 80µg/L'}, 'identificationModule': {'nctId': 'NCT03413267', 'briefTitle': 'Impact of Food Structure on Micronutrient Bioavailability in Human', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'officialTitle': 'Impact of Food Structure on Micronutrient Biovailability in Human', 'orgStudyIdInfo': {'id': 'MicroNut'}, 'secondaryIdInfos': [{'id': '2017-A01996-47', 'type': 'OTHER', 'domain': 'French Health Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Custard', 'description': 'The food matrix ingested (once by each volunteer) is a custard containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein', 'interventionNames': ['Other: Custard']}, {'type': 'EXPERIMENTAL', 'label': 'Flan', 'description': 'The food matrix ingested (once by each volunteer) is a flan containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein', 'interventionNames': ['Other: Flan']}, {'type': 'EXPERIMENTAL', 'label': 'Sponge cake', 'description': 'The food matrix ingested (once by each volunteer) is a sponge cake containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein', 'interventionNames': ['Other: Sponge cake']}, {'type': 'EXPERIMENTAL', 'label': 'Biscuit', 'description': 'The food matrix ingested (once by each volunteer) is biscuits containing 1250µg vitamin D (=50 000 UI), 12µg vitamin B12, 1000µg vitamin B9 and 20 mg lutein', 'interventionNames': ['Other: Biscuit']}], 'interventions': [{'name': 'Custard', 'type': 'OTHER', 'description': 'Food matrix: custard (liquid emulsion)', 'armGroupLabels': ['Custard']}, {'name': 'Flan', 'type': 'OTHER', 'description': 'Food matrix: flan (soft gel)', 'armGroupLabels': ['Flan']}, {'name': 'Sponge cake', 'type': 'OTHER', 'description': 'Food matrix: sponge cake (porous and spongy)', 'armGroupLabels': ['Sponge cake']}, {'name': 'Biscuit', 'type': 'OTHER', 'description': 'Food matrix: biscuit (thick and crunchy)', 'armGroupLabels': ['Biscuit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63009', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "Centre de Recherche en Nutrition HUmaine d'Auvergne", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Ruddy Richard, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de Recherche en Nutrition Humaine d'Auvergne"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by Qualiment'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Françoise Nau', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': "Université d'Auvergne", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Françoise Nau', 'investigatorAffiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}}}}