Acceptability Among Children and Caregivers of Amylase Porridges

NCT ID: NCT02192892

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CSB drum dried + α-amylase

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

Group Type EXPERIMENTAL

CSB drum dried + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB drum dried - α-amylase

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

Group Type PLACEBO_COMPARATOR

CSB drum dried + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB + α-amylase

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

Group Type EXPERIMENTAL

CSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB - α-amylase

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

Group Type PLACEBO_COMPARATOR

CSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

RSB + α-amylase

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

Group Type EXPERIMENTAL

RSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

RSB - α-amylase

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

Group Type PLACEBO_COMPARATOR

RSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

WSB + α-amylase

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

Group Type ACTIVE_COMPARATOR

WSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

Commercial porridge flour

Porridge from commercial porridge flour

Group Type ACTIVE_COMPARATOR

Commercial porridge flour

Intervention Type DIETARY_SUPPLEMENT

Porridge from commercial porridge flour

Commercial porridge bar

Porridge from commercial porridge bar

Group Type ACTIVE_COMPARATOR

Commercial porridge bar

Intervention Type DIETARY_SUPPLEMENT

Porridge from commercial porridge bar

CSB PLUS drum dried + α-amylase

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

Group Type EXPERIMENTAL

CSB PLUS drum dried + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB PLUS drum dried - α-amylase

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

Group Type PLACEBO_COMPARATOR

CSB PLUS drum dried + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB PLUS + α-amylase

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

Group Type EXPERIMENTAL

CSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

CSB PLUS - α-amylase

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

Group Type PLACEBO_COMPARATOR

CSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

RSB PLUS + α-amylase

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

Group Type EXPERIMENTAL

RSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

RSB PLUS - α-amylase

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

Group Type PLACEBO_COMPARATOR

RSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

WSB PLUS + α-amylase

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

Group Type EXPERIMENTAL

WSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

WSB PLUS - α-amylase

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

Group Type PLACEBO_COMPARATOR

WSB PLUS + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

Commercial MSB + α-amylase

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

Group Type ACTIVE_COMPARATOR

Commercial MSB + α-amylase

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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CSB drum dried + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

CSB + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

RSB + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

WSB + α-amylase

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

CSB PLUS + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

RSB PLUS + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

WSB PLUS + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

Commercial porridge flour

Porridge from commercial porridge flour

Intervention Type DIETARY_SUPPLEMENT

Commercial porridge bar

Porridge from commercial porridge bar

Intervention Type DIETARY_SUPPLEMENT

Commercial MSB + α-amylase

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United Nations World Food Programme (WFP)

OTHER

Sponsor Role collaborator

DSM Food Specialties

INDUSTRY

Sponsor Role lead

Responsible Party

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Van Hoan Nguyen

Program Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GRET

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

Site Status

Countries

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Burkina Faso

References

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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.

Reference Type DERIVED
PMID: 28466569 (View on PubMed)

Other Identifiers

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2013-10-28-AmyVisc

Identifier Type: -

Identifier Source: org_study_id

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