Clinical trial NCT02192892: Acceptability Among Children and Caregivers of Amylase Porridges
Official title: Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Young children
Acceptability
Food intake
Energy dense porridge
Lead sponsor: DSM Food Specialties
Sponsor class: INDUSTRY
Collaborators: name: United Nations World Food Programme (WFP)
First posted: 2014-07-17
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

The 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 12 to 36 months
* Anthropometry (for children only): MUAC \> 115 mm
* Informed signed consent of parents/caregivers
* Beside breastfeeding, children are used to consume complementary foods

Exclusion Criteria:

* Illness or any medical complications at the recruitment time
* Children already enrolled in any Feeding Program

Primary outcomes:
measure: Energy intake by children
timeFrame: 1 day
Secondary outcomes:
measure: Viscosity of porridge
timeFrame: 1 day
measure: Micronutrient and macronutrient intake by children
timeFrame: 1 day
measure: Acceptability of porridge by caregivers
timeFrame: 1 day
Other outcomes:
Locations:
city: Fada N'Gourma
country: Burkina Faso
facility: GRET
state: Fada N'Gourma Province
Study officials:
References:
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.