Acceptability Among Children and Caregivers of Amylase Porridges (AMY-01)

Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: CSB drum dried + α-amylase; Dietary supplement: CSB + α-amylase; Dietary supplement: RSB + α-amylase; Dietary supplement: WSB + α-amylase; Dietary supplement: Commercial porridge flour; Dietary supplement: Commercial porridge bar; Dietary supplement: CSB PLUS drum dried + α-amylase; Dietary supplement: CSB PLUS + α-amylase; Dietary supplement: RSB PLUS + α-amylase; Dietary supplement: WSB PLUS + α-amylase; Dietary supplement: Commercial MSB + α-amylase

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Fada N'Gourma Province
    • Fada N'Gourma, Fada N'Gourma Province, Burkina Faso
      • GRET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSB drum dried + α-amylase; CSB drum dried + α-amylase: Porridge from Corn Soy Blend drum dried with α-amylase	Dietary supplement: CSB drum dried + α-amylase; CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase
Placebo Comparator: CSB drum dried - α-amylase; CSB drum dried - α-amylase: Porridge from Corn Soy Blend drum dried without α-amylase	Dietary supplement: CSB drum dried + α-amylase; CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase
Experimental: CSB + α-amylase; CSB + α-amylase: Porridge from Corn Soy Blend with α-amylase	Dietary supplement: CSB + α-amylase; CSB + α-amylase: porridge from Corn Soy Blend with α-amylase
Placebo Comparator: CSB - α-amylase; CSB - α-amylase: Porridge from Corn Soy Blend without α-amylase	Dietary supplement: CSB + α-amylase; CSB + α-amylase: porridge from Corn Soy Blend with α-amylase
Experimental: RSB + α-amylase; RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase	Dietary supplement: RSB + α-amylase; RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase
Placebo Comparator: RSB - α-amylase; RSB - α-amylase: Porridge from Rice Soy Blend without α-amylase	Dietary supplement: RSB + α-amylase; RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase
Active Comparator: WSB + α-amylase; WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase	Dietary supplement: WSB + α-amylase; WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase
Active Comparator: Commercial porridge flour; Porridge from commercial porridge flour	Dietary supplement: Commercial porridge flour; Porridge from commercial porridge flour
Active Comparator: Commercial porridge bar; Porridge from commercial porridge bar	Dietary supplement: Commercial porridge bar; Porridge from commercial porridge bar
Experimental: CSB PLUS drum dried + α-amylase; CSB PLUS drum dried + α-amylase: Porridge from Corn Soy Blend PLUS drum dried with α-amylase	Dietary supplement: CSB PLUS drum dried + α-amylase; CSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase
Placebo Comparator: CSB PLUS drum dried - α-amylase; CSB PLUS drum dried - α-amylase: Porridge from Corn Soy Blend PLUS drum dried without α-amylase	Dietary supplement: CSB PLUS drum dried + α-amylase; CSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase
Experimental: CSB PLUS + α-amylase; CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase	Dietary supplement: CSB PLUS + α-amylase; CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase
Placebo Comparator: CSB PLUS - α-amylase; CSB PLUS - α-amylase: Porridge from Corn Soy Blend PLUS without α-amylase	Dietary supplement: CSB PLUS + α-amylase; CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase
Experimental: RSB PLUS + α-amylase; RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase	Dietary supplement: RSB PLUS + α-amylase; RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase
Placebo Comparator: RSB PLUS - α-amylase; RSB PLUS - α-amylase: Porridge from Rice Soy Blend PLUS without α-amylase	Dietary supplement: RSB PLUS + α-amylase; RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase
Experimental: WSB PLUS + α-amylase; WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase	Dietary supplement: WSB PLUS + α-amylase; WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase
Placebo Comparator: WSB PLUS - α-amylase; WSB PLUS - α-amylase: Porridge from Wheat Soy Blend PLUS without α-amylase	Dietary supplement: WSB PLUS + α-amylase; WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase
Active Comparator: Commercial MSB + α-amylase; Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase	Dietary supplement: Commercial MSB + α-amylase; Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake by children	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.	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DSM Food Specialties
• Collaborators: United Nations World Food Programme (WFP)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Acceptability; Food intake; Young children; Energy dense porridge
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 2013-10-28-AmyVisc