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Completed

NCT Number: NCT02192892

Acceptability Among Children and Caregivers of Amylase Porridges

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.

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Key information

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GRET

Fada N'gourma, Fada N'Gourma Province, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSB drum dried + α-amylase

Dietary Supplement

CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase

CSB + α-amylase

Dietary Supplement

CSB + α-amylase: porridge from Corn Soy Blend with α-amylase

RSB + α-amylase

Dietary Supplement

RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase

WSB + α-amylase

Dietary Supplement

WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase

CSB PLUS drum dried + α-amylase

Dietary Supplement

CSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase

CSB PLUS + α-amylase

Dietary Supplement

CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase

RSB PLUS + α-amylase

Dietary Supplement

RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase

WSB PLUS + α-amylase

Dietary Supplement

WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase

Commercial porridge flour

Dietary Supplement

Porridge from commercial porridge flour

Commercial porridge bar

Dietary Supplement

Porridge from commercial porridge bar

Commercial MSB + α-amylase

Dietary Supplement

Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase

Primary outcomes

  1. Energy intake by children

    Time frame: 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 outcomes

  1. Viscosity of porridge

    Time frame: 1 day

    Viscosity by Bostwick consistometer (cm/30 secs). Mean of three measures on three different days.

  2. Micronutrient and macronutrient intake by children

    Time frame: 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.

  3. Acceptability of porridge by caregivers

    Time frame: 1 day

    Acceptability of caregivers ("liking" on a 5-point Hedonic scale, by ranking and by interview)

Sponsors and collaborators

Lead sponsor

DSM Food Specialties

Industry

Collaborators

  • United Nations World Food Programme (WFP)

Registry information

Official study title

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

Acronym: AMY-01

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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