NCT02192892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

June 12, 2014

Last Update Submit

August 5, 2014

Conditions

Malnutrition

Keywords

Young childrenAcceptabilityFood intakeEnergy dense porridge

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Viscosity of porridge

    1 day

  • Micronutrient and macronutrient intake by children

    1 day

  • Acceptability of porridge by caregivers

    1 day

Study Arms (18)

CSB drum dried + α-amylase

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Dietary Supplement: CSB drum dried + α-amylase

CSB + α-amylase

EXPERIMENTAL

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

Dietary Supplement: CSB + α-amylase

CSB - α-amylase

PLACEBO COMPARATOR

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

Dietary Supplement: CSB + α-amylase

RSB + α-amylase

EXPERIMENTAL

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

Dietary Supplement: RSB + α-amylase

RSB - α-amylase

PLACEBO COMPARATOR

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

Dietary Supplement: RSB + α-amylase

WSB + α-amylase

ACTIVE COMPARATOR

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

Dietary Supplement: WSB + α-amylase

Commercial porridge flour

ACTIVE COMPARATOR

Porridge from commercial porridge flour

Dietary Supplement: Commercial porridge flour

Commercial porridge bar

ACTIVE COMPARATOR

Porridge from commercial porridge bar

Dietary Supplement: Commercial porridge bar

CSB PLUS drum dried + α-amylase

EXPERIMENTAL

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

PLACEBO COMPARATOR

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 + α-amylase

EXPERIMENTAL

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

Dietary Supplement: CSB PLUS + α-amylase

CSB PLUS - α-amylase

PLACEBO COMPARATOR

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

Dietary Supplement: CSB PLUS + α-amylase

RSB PLUS + α-amylase

EXPERIMENTAL

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

Dietary Supplement: RSB PLUS + α-amylase

RSB PLUS - α-amylase

PLACEBO COMPARATOR

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

Dietary Supplement: RSB PLUS + α-amylase

WSB PLUS + α-amylase

EXPERIMENTAL

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

Dietary Supplement: WSB PLUS + α-amylase

WSB PLUS - α-amylase

PLACEBO COMPARATOR

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

Dietary Supplement: WSB PLUS + α-amylase

Commercial MSB + α-amylase

ACTIVE COMPARATOR

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

Dietary Supplement: Commercial MSB + α-amylase

Interventions

CSB drum dried + α-amylaseDIETARY_SUPPLEMENT

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

CSB drum dried + α-amylaseCSB drum dried - α-amylase
CSB + α-amylaseDIETARY_SUPPLEMENT

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

CSB + α-amylaseCSB - α-amylase
RSB + α-amylaseDIETARY_SUPPLEMENT

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

RSB + α-amylaseRSB - α-amylase
WSB + α-amylaseDIETARY_SUPPLEMENT

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

WSB + α-amylase
CSB PLUS drum dried + α-amylaseDIETARY_SUPPLEMENT

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

CSB PLUS drum dried + α-amylaseCSB PLUS drum dried - α-amylase
CSB PLUS + α-amylaseDIETARY_SUPPLEMENT

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

CSB PLUS + α-amylaseCSB PLUS - α-amylase
RSB PLUS + α-amylaseDIETARY_SUPPLEMENT

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

RSB PLUS + α-amylaseRSB PLUS - α-amylase
WSB PLUS + α-amylaseDIETARY_SUPPLEMENT

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

WSB PLUS + α-amylaseWSB PLUS - α-amylase
Commercial porridge flourDIETARY_SUPPLEMENT

Porridge from commercial porridge flour

Commercial porridge flour
Commercial porridge barDIETARY_SUPPLEMENT

Porridge from commercial porridge bar

Commercial porridge bar
Commercial MSB + α-amylaseDIETARY_SUPPLEMENT

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

Commercial MSB + α-amylase

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GRET

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

Location

Related Publications (1)

  • 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.

    PMID: 28466569DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Placental Lactogen

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Placental HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Officer

Study Record Dates

First Submitted

June 12, 2014

First Posted

July 17, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

BU(1)