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

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ClinicalTrials.gov Identifier: NCT02192892
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
United Nations World Food Programme (WFP)
Information provided by (Responsible Party):
Van Hoan Nguyen, United Nations World Food Programme (WFP)

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.


Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: CSB drum dried + α-amylase Dietary Supplement: CSB + α-amylase Dietary Supplement: RSB + α-amylase Dietary Supplement: WSB + α-amylase 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 porridge flour Dietary Supplement: Commercial porridge bar Dietary Supplement: Commercial MSB + α-amylase Not Applicable

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192892


Locations
Burkina Faso
GRET
Fada N'Gourma, Fada N'Gourma Province, Burkina Faso
Sponsors and Collaborators
DSM Food Specialties
United Nations World Food Programme (WFP)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Van Hoan Nguyen, Program Officer, United Nations World Food Programme (WFP)
ClinicalTrials.gov Identifier: NCT02192892     History of Changes
Other Study ID Numbers: 2013-10-28-AmyVisc
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by Van Hoan Nguyen, United Nations World Food Programme (WFP):
Young children
Acceptability
Food intake
Energy dense porridge

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders