MalnutritionAMY-01NCT02192892
Acceptability Among Children and Caregivers of Amylase Porridges
A study testing CSB drum dried + α-amylase, CSB + α-amylase and RSB + α-amylase in people with Malnutrition, run by DSM Food Specialties at 1 site in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- CSB drum dried + α-amylase, CSB + α-amylase and RSB + α-amylase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jun 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Illness or any medical complications at the recruitment time
- Children already enrolled in any Feeding Program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- CSB drum dried + α-amylase, CSB + α-amylase, RSB + α-amylase, WSB + α-amylase, CSB PLUS drum dried + α-amylase
- Keywords
- Young children, Acceptability, Food intake, Energy dense porridge
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSB drum dried + α-amylaseDietary supplement
CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase
CSB + α-amylaseDietary supplement
CSB + α-amylase: porridge from Corn Soy Blend with α-amylase
RSB + α-amylaseDietary supplement
RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase
WSB + α-amylaseDietary supplement
WSB + α-amylase: Porridge from Wheat Soy Blend with 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 + α-amylaseDietary supplement
CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase
RSB PLUS + α-amylaseDietary supplement
RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase
WSB PLUS + α-amylaseDietary supplement
WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase
Commercial porridge flourDietary supplement
Porridge from commercial porridge flour
Commercial porridge barDietary supplement
Porridge from commercial porridge bar
Commercial MSB + α-amylaseDietary supplement
Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase
| Study group | Role | What they receive |
|---|---|---|
| CSB drum dried + α-amylase | Experimental | CSB drum dried + α-amylase: Porridge from Corn Soy Blend drum dried with α-amylase Receives: 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 Receives: Dietary Supplement: CSB drum dried + α-amylase |
| CSB + α-amylase | Experimental | CSB + α-amylase: Porridge from Corn Soy Blend with α-amylase Receives: Dietary Supplement: CSB + α-amylase |
| CSB - α-amylase | Placebo comparator | CSB - α-amylase: Porridge from Corn Soy Blend without α-amylase Receives: Dietary Supplement: CSB + α-amylase |
| RSB + α-amylase | Experimental | RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase Receives: Dietary Supplement: RSB + α-amylase |
| RSB - α-amylase | Placebo comparator | RSB - α-amylase: Porridge from Rice Soy Blend without α-amylase Receives: Dietary Supplement: RSB + α-amylase |
| WSB + α-amylase | Active comparator | WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase Receives: Dietary Supplement: WSB + α-amylase |
| Commercial porridge flour | Active comparator | Porridge from commercial porridge flour Receives: Dietary Supplement: Commercial porridge flour |
| Commercial porridge bar | Active comparator | Porridge from commercial porridge bar Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: CSB PLUS + α-amylase |
| RSB PLUS + α-amylase | Experimental | RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase Receives: 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 Receives: Dietary Supplement: RSB PLUS + α-amylase |
| WSB PLUS + α-amylase | Experimental | WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase Receives: 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 Receives: 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 Receives: Dietary Supplement: Commercial MSB + α-amylase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
Viscosity of porridge
Viscosity by Bostwick consistometer (cm/30 secs). Mean of three measures on three different days.
Measured: 1 day
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.
Measured: 1 day
Acceptability of porridge by caregivers
Acceptability of caregivers ("liking" on a 5-point Hedonic scale, by ranking and by interview)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- DSM Food Specialties
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United Nations World Food Programme (WFP)
- Responsible party
- Principal investigator, Van Hoan Nguyen, United Nations World Food Programme (WFP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192892
- Sponsor's protocol ID
- 2013-10-28-AmyVisc
- Acronym
- AMY-01
- Status last verified
- Aug 2014
- First submitted
- 12 Jun 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28466569
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of α-amylase Fortified Blended Foods Among Children 12-36 Months Old Children and Caregivers in Burkina Faso
- ClinicalTrials.gov ID
- NCT02192892
- Acronym / sponsor ID
- AMY-01 / 2013-10-28-AmyVisc
- Conditions
- Malnutrition
- Keywords
- Young children, Acceptability, Food intake, Energy dense porridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- DSM Food SpecialtiesIndustry (pharma, biotech, devices)
- Collaborators
- United Nations World Food Programme (WFP)
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| CSB drum dried + α-amylase | Experimental | Dietary Supplement: CSB drum dried + α-amylaseCSB drum dried + α-amylase: Porridge from Corn Soy Blend drum dried with α-amylase |
| CSB drum dried - α-amylase | Placebo comparator | Dietary Supplement: CSB drum dried + α-amylaseCSB drum dried - α-amylase: Porridge from Corn Soy Blend drum dried without α-amylase |
| CSB + α-amylase | Experimental | Dietary Supplement: CSB + α-amylaseCSB + α-amylase: Porridge from Corn Soy Blend with α-amylase |
| CSB - α-amylase | Placebo comparator | Dietary Supplement: CSB + α-amylaseCSB - α-amylase: Porridge from Corn Soy Blend without α-amylase |
| RSB + α-amylase | Experimental | Dietary Supplement: RSB + α-amylaseRSB + α-amylase: Porridge from Rice Soy Blend with α-amylase |
| RSB - α-amylase | Placebo comparator | Dietary Supplement: RSB + α-amylaseRSB - α-amylase: Porridge from Rice Soy Blend without α-amylase |
| WSB + α-amylase | Active comparator | Dietary Supplement: WSB + α-amylaseWSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase |
| Commercial porridge flour | Active comparator | Dietary Supplement: Commercial porridge flourPorridge from commercial porridge flour |
| Commercial porridge bar | Active comparator | Dietary Supplement: Commercial porridge barPorridge from commercial porridge bar |
| CSB PLUS drum dried + α-amylase | Experimental | Dietary Supplement: CSB PLUS drum dried + α-amylaseCSB PLUS drum dried + α-amylase: Porridge from Corn Soy Blend PLUS drum dried with α-amylase |
| CSB PLUS drum dried - α-amylase | Placebo comparator | Dietary Supplement: CSB PLUS drum dried + α-amylaseCSB PLUS drum dried - α-amylase: Porridge from Corn Soy Blend PLUS drum dried without α-amylase |
| CSB PLUS + α-amylase | Experimental | Dietary Supplement: CSB PLUS + α-amylaseCSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase |
| CSB PLUS - α-amylase | Placebo comparator | Dietary Supplement: CSB PLUS + α-amylaseCSB PLUS - α-amylase: Porridge from Corn Soy Blend PLUS without α-amylase |
| RSB PLUS + α-amylase | Experimental | Dietary Supplement: RSB PLUS + α-amylaseRSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase |
| RSB PLUS - α-amylase | Placebo comparator | Dietary Supplement: RSB PLUS + α-amylaseRSB PLUS - α-amylase: Porridge from Rice Soy Blend PLUS without α-amylase |
| WSB PLUS + α-amylase | Experimental | Dietary Supplement: WSB PLUS + α-amylaseWSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase |
| WSB PLUS - α-amylase | Placebo comparator | Dietary Supplement: WSB PLUS + α-amylaseWSB PLUS - α-amylase: Porridge from Wheat Soy Blend PLUS without α-amylase |
| Commercial MSB + α-amylase | Active comparator | Dietary Supplement: Commercial MSB + α-amylaseCommercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Illness or any medical complications at the recruitment time
- Children already enrolled in any Feeding Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSB drum dried + α-amylaseCSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase | Dietary supplement | CSB drum dried + α-amylase, CSB drum dried - α-amylase |
| CSB + α-amylaseCSB + α-amylase: porridge from Corn Soy Blend with α-amylase | Dietary supplement | CSB + α-amylase, CSB - α-amylase |
| RSB + α-amylaseRSB + α-amylase: Porridge from Rice Soy Blend with α-amylase | Dietary supplement | RSB + α-amylase, RSB - α-amylase |
| WSB + α-amylaseWSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase | Dietary supplement | WSB + α-amylase |
| CSB PLUS drum dried + α-amylaseCSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase | Dietary supplement | CSB PLUS drum dried + α-amylase, CSB PLUS drum dried - α-amylase |
| CSB PLUS + α-amylaseCSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase | Dietary supplement | CSB PLUS + α-amylase, CSB PLUS - α-amylase |
| RSB PLUS + α-amylaseRSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase | Dietary supplement | RSB PLUS + α-amylase, RSB PLUS - α-amylase |
| WSB PLUS + α-amylaseWSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase | Dietary supplement | WSB PLUS + α-amylase, WSB PLUS - α-amylase |
| Commercial porridge flourPorridge from commercial porridge flour | Dietary supplement | Commercial porridge flour |
| Commercial porridge barPorridge from commercial porridge bar | Dietary supplement | Commercial porridge bar |
| Commercial MSB + α-amylaseCommercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase | Dietary supplement | Commercial MSB + α-amylase |
Primary outcome
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.
3 secondary outcomes
Viscosity of porridge
Time frame: 1 day
Micronutrient and macronutrient intake by children
Time frame: 1 day
Acceptability of porridge by caregivers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 28466569Kampstra 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.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSB drum dried + α-amylase, CSB + α-amylase and RSB + α-amylase in people with Malnutrition, run by DSM Food Specialties at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake by children (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.