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临床试验/NCT02192892
NCT02192892已完成不适用

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

DSM Food Specialties2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Energy intake by children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Illness or any medical complications at the recruitment time
  • Children already enrolled in any Feeding Program

研究组 & 干预措施

WSB + α-amylase

Active Comparator

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

干预措施: WSB + α-amylase (Dietary Supplement)

Commercial porridge flour

Active Comparator

Porridge from commercial porridge flour

干预措施: Commercial porridge flour (Dietary Supplement)

Commercial porridge bar

Active Comparator

Porridge from commercial porridge bar

干预措施: Commercial porridge bar (Dietary Supplement)

CSB PLUS drum dried + α-amylase

Experimental

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

干预措施: CSB PLUS drum dried + α-amylase (Dietary Supplement)

CSB drum dried + α-amylase

Experimental

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

干预措施: CSB drum dried + α-amylase (Dietary Supplement)

CSB drum dried - α-amylase

Placebo Comparator

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

干预措施: CSB drum dried + α-amylase (Dietary Supplement)

CSB + α-amylase

Experimental

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

干预措施: CSB + α-amylase (Dietary Supplement)

CSB - α-amylase

Placebo Comparator

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

干预措施: CSB + α-amylase (Dietary Supplement)

RSB + α-amylase

Experimental

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

干预措施: RSB + α-amylase (Dietary Supplement)

RSB - α-amylase

Placebo Comparator

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

干预措施: RSB + α-amylase (Dietary Supplement)

CSB PLUS drum dried - α-amylase

Placebo Comparator

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

干预措施: CSB PLUS drum dried + α-amylase (Dietary Supplement)

CSB PLUS + α-amylase

Experimental

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

干预措施: CSB PLUS + α-amylase (Dietary Supplement)

CSB PLUS - α-amylase

Placebo Comparator

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

干预措施: CSB PLUS + α-amylase (Dietary Supplement)

RSB PLUS + α-amylase

Experimental

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

干预措施: RSB PLUS + α-amylase (Dietary Supplement)

RSB PLUS - α-amylase

Placebo Comparator

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

干预措施: RSB PLUS + α-amylase (Dietary Supplement)

WSB PLUS + α-amylase

Experimental

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

干预措施: WSB PLUS + α-amylase (Dietary Supplement)

WSB PLUS - α-amylase

Placebo Comparator

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

干预措施: WSB PLUS + α-amylase (Dietary Supplement)

Commercial MSB + α-amylase

Active Comparator

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

干预措施: Commercial MSB + α-amylase (Dietary Supplement)

结局指标

主要结局

Energy intake by children

时间窗: 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.

次要结局

  • Viscosity of porridge(1 day)
  • Acceptability of porridge by caregivers(1 day)
  • Micronutrient and macronutrient intake by children(1 day)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Van Hoan Nguyen

Program Officer

United Nations World Food Programme (WFP)

研究点 (2)

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