Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-03-06 @ 9:38 AM
Study NCT ID:
NCT02192892
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2014-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability Among Children and Caregivers of Amylase Porridges
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010928', 'term': 'Placental Lactogen'}], 'ancestors': [{'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake by children', 'timeFrame': '1 day', 'description': 'Energy intake (kcal/d) by children calculated on the basis of actual intake of wet weight porridge and converted into dry weight (grams). Mean of three measures on three different days.'}], 'secondaryOutcomes': [{'measure': 'Viscosity of porridge', 'timeFrame': '1 day', 'description': 'Viscosity by Bostwick consistometer (cm/30 secs). Mean of three measures on three different days.'}, {'measure': 'Micronutrient and macronutrient intake by children', 'timeFrame': '1 day', 'description': 'Micronutrient and macronutrient intake (mg/d) children calculated on the basis of actual intake of wet weight porridge and converted into dry weight (grams). Mean of three measures on three different days.'}, {'measure': 'Acceptability of porridge by caregivers', 'timeFrame': '1 day', 'description': 'Acceptability of caregivers ("liking" on a 5-point Hedonic scale, by ranking and by interview)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Young children', 'Acceptability', 'Food intake', 'Energy dense porridge'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '28466569', 'type': 'DERIVED', 'citation': 'Kampstra NA, Van Hoan N, Koenders DJPC, Schoop R, Broersen BC, Mouquet-Rivier C, Traore T, Bruins MJ, de Pee S. Energy and nutrient intake increased by 47-67% when amylase was added to fortified blended foods-a study among 12- to 35-month-old Burkinabe children. Matern Child Nutr. 2018 Jan;14(1):e12459. doi: 10.1111/mcn.12459. Epub 2017 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Addition of α-amylase is considered as one of most effective solution to improve energy density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of porridges will be decreased while keeping dry matter content constant. Potential positive impact is to significantly improve efficiency of WFP nutritional programmes targeting vulnerable groups suffering from acute malnutrition.\n\nThe acceptance of porridges made with α-amylase is tested compared to porridges made without α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based on energy intake. The porridges tested consist of fortified blended Supercereal (12- \\<24 months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a commercial porridge, or eeZee bar.', 'detailedDescription': "In total 120 caregiver-child pairs will be recruited in in a rural area in Fada N'Gourma Province, Burkina Faso. In total 240 subjects are included in the study: 80 children aged 12-23.9 months with 80 caregivers and 40 children aged 24-36 months with 40 caregivers. Per group (12-23.9 months or 24-36 months) 10 porridges will be prepare according to cooking instructions at central points of the villages where children are living. The caregiver will feed porridge to their children. Children eat as much porridge as they like. Porridge energy, micro- and macronutrient intake will be determined and porridge viscosity. Children and caregivers are randomly assigned to 10 different porridges, one meal per day and 3 consecutive days per porridge. Total duration is consecutively 30 days. The 120 caregivers will participate in a sensory test. At the end of the study, all caregivers will evaluate sensory of 5 out of the 10 porridges by survey, by ranking and by interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 12 to 36 months\n* Anthropometry (for children only): MUAC \\> 115 mm\n* Informed signed consent of parents/caregivers\n* Beside breastfeeding, children are used to consume complementary foods\n\nExclusion Criteria:\n\n* Illness or any medical complications at the recruitment time\n* Children already enrolled in any Feeding Program'}, 'identificationModule': {'nctId': 'NCT02192892', 'acronym': 'AMY-01', 'briefTitle': 'Acceptability Among Children and Caregivers of Amylase Porridges', 'organization': {'class': 'INDUSTRY', 'fullName': 'DSM Food Specialties'}, 'officialTitle': 'Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso', 'orgStudyIdInfo': {'id': '2013-10-28-AmyVisc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSB drum dried + α-amylase', 'description': 'CSB drum dried + α-amylase: Porridge from Corn Soy Blend drum dried with α-amylase', 'interventionNames': ['Dietary Supplement: CSB drum dried + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSB drum dried - α-amylase', 'description': 'CSB drum dried - α-amylase: Porridge from Corn Soy Blend drum dried without α-amylase', 'interventionNames': ['Dietary Supplement: CSB drum dried + α-amylase']}, {'type': 'EXPERIMENTAL', 'label': 'CSB + α-amylase', 'description': 'CSB + α-amylase: Porridge from Corn Soy Blend with α-amylase', 'interventionNames': ['Dietary Supplement: CSB + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSB - α-amylase', 'description': 'CSB - α-amylase: Porridge from Corn Soy Blend without α-amylase', 'interventionNames': ['Dietary Supplement: CSB + α-amylase']}, {'type': 'EXPERIMENTAL', 'label': 'RSB + α-amylase', 'description': 'RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase', 'interventionNames': ['Dietary Supplement: RSB + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'RSB - α-amylase', 'description': 'RSB - α-amylase: Porridge from Rice Soy Blend without α-amylase', 'interventionNames': ['Dietary Supplement: RSB + α-amylase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WSB + α-amylase', 'description': 'WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase', 'interventionNames': ['Dietary Supplement: WSB + α-amylase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial porridge flour', 'description': 'Porridge from commercial porridge flour', 'interventionNames': ['Dietary Supplement: Commercial porridge flour']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial porridge bar', 'description': 'Porridge from commercial porridge bar', 'interventionNames': ['Dietary Supplement: Commercial porridge bar']}, {'type': 'EXPERIMENTAL', 'label': 'CSB PLUS drum dried + α-amylase', 'description': 'CSB PLUS drum dried + α-amylase: Porridge from Corn Soy Blend PLUS drum dried with α-amylase', 'interventionNames': ['Dietary Supplement: CSB PLUS drum dried + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSB PLUS drum dried - α-amylase', 'description': 'CSB PLUS drum dried - α-amylase: Porridge from Corn Soy Blend PLUS drum dried without α-amylase', 'interventionNames': ['Dietary Supplement: CSB PLUS drum dried + α-amylase']}, {'type': 'EXPERIMENTAL', 'label': 'CSB PLUS + α-amylase', 'description': 'CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase', 'interventionNames': ['Dietary Supplement: CSB PLUS + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSB PLUS - α-amylase', 'description': 'CSB PLUS - α-amylase: Porridge from Corn Soy Blend PLUS without α-amylase', 'interventionNames': ['Dietary Supplement: CSB PLUS + α-amylase']}, {'type': 'EXPERIMENTAL', 'label': 'RSB PLUS + α-amylase', 'description': 'RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase', 'interventionNames': ['Dietary Supplement: RSB PLUS + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'RSB PLUS - α-amylase', 'description': 'RSB PLUS - α-amylase: Porridge from Rice Soy Blend PLUS without α-amylase', 'interventionNames': ['Dietary Supplement: RSB PLUS + α-amylase']}, {'type': 'EXPERIMENTAL', 'label': 'WSB PLUS + α-amylase', 'description': 'WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase', 'interventionNames': ['Dietary Supplement: WSB PLUS + α-amylase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'WSB PLUS - α-amylase', 'description': 'WSB PLUS - α-amylase: Porridge from Wheat Soy Blend PLUS without α-amylase', 'interventionNames': ['Dietary Supplement: WSB PLUS + α-amylase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial MSB + α-amylase', 'description': 'Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase', 'interventionNames': ['Dietary Supplement: Commercial MSB + α-amylase']}], 'interventions': [{'name': 'CSB drum dried + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase', 'armGroupLabels': ['CSB drum dried + α-amylase', 'CSB drum dried - α-amylase']}, {'name': 'CSB + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'CSB + α-amylase: porridge from Corn Soy Blend with α-amylase', 'armGroupLabels': ['CSB + α-amylase', 'CSB - α-amylase']}, {'name': 'RSB + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase', 'armGroupLabels': ['RSB + α-amylase', 'RSB - α-amylase']}, {'name': 'WSB + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase', 'armGroupLabels': ['WSB + α-amylase']}, {'name': 'CSB PLUS drum dried + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'CSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase', 'armGroupLabels': ['CSB PLUS drum dried + α-amylase', 'CSB PLUS drum dried - α-amylase']}, {'name': 'CSB PLUS + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase', 'armGroupLabels': ['CSB PLUS + α-amylase', 'CSB PLUS - α-amylase']}, {'name': 'RSB PLUS + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase', 'armGroupLabels': ['RSB PLUS + α-amylase', 'RSB PLUS - α-amylase']}, {'name': 'WSB PLUS + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase', 'armGroupLabels': ['WSB PLUS + α-amylase', 'WSB PLUS - α-amylase']}, {'name': 'Commercial porridge flour', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Porridge from commercial porridge flour', 'armGroupLabels': ['Commercial porridge flour']}, {'name': 'Commercial porridge bar', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Porridge from commercial porridge bar', 'armGroupLabels': ['Commercial porridge bar']}, {'name': 'Commercial MSB + α-amylase', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase', 'armGroupLabels': ['Commercial MSB + α-amylase']}]}, 'contactsLocationsModule': {'locations': [{'city': "Fada N'gourma", 'state': "Fada N'Gourma Province", 'country': 'Burkina Faso', 'facility': 'GRET', 'geoPoint': {'lat': 12.06157, 'lon': 0.35843}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DSM Food Specialties', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'United Nations World Food Programme (WFP)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Officer', 'investigatorFullName': 'Van Hoan Nguyen', 'investigatorAffiliation': 'United Nations World Food Programme (WFP)'}}}}