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

DSM Nutritional Products

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: RSB + α-amylase; Dietary Supplement: Commercial MSB + α-amylase; Dietary Supplement: CSB PLUS + α-amylase; Dietary Supplement: CSB + α-amylase; Dietary Supplement: Commercial porridge flour; Dietary Supplement: CSB drum dried + α-amylase; Dietary Supplement: RSB PLUS + α-amylase; Dietary Supplement: Commercial porridge bar; Dietary Supplement: CSB PLUS drum dried + α-amylase; Dietary Supplement: WSB + α-amylase; Dietary Supplement: WSB PLUS + α-amylase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02192892

2013-10-28-AmyVisc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

240 participants in 18 patient groups, including a placebo group

CSB drum dried + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: CSB drum dried + α-amylase

CSB drum dried - α-amylase

Placebo Comparator group

Description:

CSB drum dried - α-amylase: Porridge from Corn Soy Blend drum dried without α-amylase

Treatment:

Dietary Supplement: CSB drum dried + α-amylase

CSB + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: CSB + α-amylase

CSB - α-amylase

Placebo Comparator group

Description:

CSB - α-amylase: Porridge from Corn Soy Blend without α-amylase

Treatment:

Dietary Supplement: CSB + α-amylase

RSB + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: RSB + α-amylase

RSB - α-amylase

Placebo Comparator group

Description:

RSB - α-amylase: Porridge from Rice Soy Blend without α-amylase

Treatment:

Dietary Supplement: RSB + α-amylase

WSB + α-amylase

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: WSB + α-amylase

Commercial porridge flour

Active Comparator group

Description:

Porridge from commercial porridge flour

Treatment:

Dietary Supplement: Commercial porridge flour

Commercial porridge bar

Active Comparator group

Description:

Porridge from commercial porridge bar

Treatment:

Dietary Supplement: Commercial porridge bar

CSB PLUS drum dried + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: CSB PLUS drum dried + α-amylase

CSB PLUS drum dried - α-amylase

Placebo Comparator group

Description:

CSB PLUS drum dried - α-amylase: Porridge from Corn Soy Blend PLUS drum dried without α-amylase

Treatment:

Dietary Supplement: CSB PLUS drum dried + α-amylase

CSB PLUS + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: CSB PLUS + α-amylase

CSB PLUS - α-amylase

Placebo Comparator group

Description:

CSB PLUS - α-amylase: Porridge from Corn Soy Blend PLUS without α-amylase

Treatment:

Dietary Supplement: CSB PLUS + α-amylase

RSB PLUS + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: RSB PLUS + α-amylase

RSB PLUS - α-amylase

Placebo Comparator group

Description:

RSB PLUS - α-amylase: Porridge from Rice Soy Blend PLUS without α-amylase

Treatment:

Dietary Supplement: RSB PLUS + α-amylase

WSB PLUS + α-amylase

Experimental group

Description:

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

Treatment:

Dietary Supplement: WSB PLUS + α-amylase

WSB PLUS - α-amylase

Placebo Comparator group

Description:

WSB PLUS - α-amylase: Porridge from Wheat Soy Blend PLUS without α-amylase

Treatment:

Dietary Supplement: WSB PLUS + α-amylase

Commercial MSB + α-amylase

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Commercial MSB + α-amylase