Acceptability Among Children and Caregivers of Amylase Porridges

Not Applicable

Completed

• Conditions: Malnutrition

• Registration Number: NCT02192892
• Lead Sponsor: DSM Food Specialties

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Energy intake by children	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Viscosity of porridge	1 day	Viscosity by Bostwick consistometer (cm/30 secs). Mean of three measures on three different days.
Acceptability of porridge by caregivers	1 day	Acceptability of caregivers ("liking" on a 5-point Hedonic scale, by ranking and by interview)
Micronutrient and macronutrient intake by children	1 day	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.

Trial Locations

Locations (1)

GRET; 🇧🇫 Fada N'Gourma, Fada N'Gourma Province, Burkina Faso