Acceptability Among Children and Caregivers of Amylase Porridges

Malnutrition Clinical Trial

— AMY-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192892
• Other study ID #: 2013-10-28-AmyVisc
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: August 5, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: DSM Food Specialties
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 36 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• CSB drum dried + a-amylase
CSB drum dried + a-amylase: Porridge from drum dried Corn Soy Blend with a-amylase
• CSB + a-amylase
CSB + a-amylase: porridge from Corn Soy Blend with a-amylase
• RSB + a-amylase
RSB + a-amylase: Porridge from Rice Soy Blend with a-amylase
• WSB + a-amylase
WSB + a-amylase: Porridge from Wheat Soy Blend with a-amylase
• CSB PLUS drum dried + a-amylase
CSB PLUS drum dried + a-amylase: Porridge from drum dried Corn Soy Blend PLUS with a-amylase
• CSB PLUS + a-amylase
CSB PLUS + a-amylase: Porridge from Corn Soy Blend PLUS with a-amylase
• RSB PLUS + a-amylase
RSB PLUS + a-amylase: Porridge from Rice Soy Blend PLUS with a-amylase
• WSB PLUS + a-amylase
WSB PLUS + a-amylase: Porridge from Wheat Soy Blend PLUS with a-amylase
• Commercial porridge flour
Porridge from commercial porridge flour
• Commercial porridge bar
Porridge from commercial porridge bar
• Commercial MSB + a-amylase
Commercial MSB + a-amylase: Commercial porridge from Mais Soy Blend with a-amylase

Locations

Country	Name	City	State
Burkina Faso	GRET	Fada N'Gourma	Fada N'Gourma Province

Sponsors (2)

Lead Sponsor	Collaborator
DSM Food Specialties	United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Viscosity of porridge	Viscosity by Bostwick consistometer (cm/30 secs). Mean of three measures on three different days.	1 day	No
Secondary	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	No
Secondary	Acceptability of porridge by caregivers	Acceptability of caregivers ("liking" on a 5-point Hedonic scale, by ranking and by interview)	1 day	No