School Feeding Programs and Nutrition SupplementsNCT02757508
Healthy and Affordable Protein Rich Foods for African Market
A study testing protein powder supplement and Vitamins/minerals in people with School Feeding Programs and Nutrition Supplements, run by Washington University School of Medicine at 2 sites in 2 countries.
Trial summary
This study is to gather information on school feeding programs and to measure the effect on linear growth and cognitive performance when providing a high-quality milk protein source or a combination of a high-quality milk protein source and rice proteins as a nutritional supplement to school children in Ghana. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- School Feeding Programs and Nutrition Supplements
- What is being tested?
- protein powder supplement and Vitamins/minerals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,041 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2016to 30 Jul 2017
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ghana school children between the ages of 6-9 years old
Who cannot join
- children with severe malnutrition
- chronic debilitation disease
- milk allergy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs
This study is to gather information on school feeding programs and to measure the effect on linear growth and cognitive performance when providing a high-quality milk protein source or a combination of a high-quality milk protein source and rice proteins as a nutritional supplement to school children in Ghana. Children will receive a meal with a protein powder supplement with vitamins and minerals mixed into it. Participation is expected to last for 9 months.
1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary schools (60 per school). Participants will be randomized to one of four groups: Control: Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF recommendations.
Read more
For groups 1-3 the same vitamin/mineral mix will be used along with Group 1. Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.
Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose.
Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.
At baseline measurements-weight,height,mid-upper arm circumference,and body composition will be taken, fasting blood spot test will be administered to measure levels of Insulin and insulin like growth factor and other metabolic test, and computer based cognitive testing. Demographic information will be collected along with a dietary survey. Primary outcomes are cognitive performance on standardized tests and change in height-for-age z-score over the supplementation period, 9 months total. Questionnaires will be administered to collect demographic data and dietary information.
At the mid-point all measurements will be taken again and cognitive testing will be repeated.
At the end of the study all measurements will be taken again, cognitive testing repeated, blood spot samples taken again, and a short survey will be administered about the protein powders.
- Being tested
- protein powder supplement, Vitamins/minerals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein powder supplementDietary supplement
Vitamins/mineralsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Vitamins/minerals-200 mg premix Receives: Dietary Supplement: Vitamins/minerals |
| Group 1 | Experimental | Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose. Receives: Dietary Supplement: protein powder supplement |
| Group 2 | Experimental | Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose. Receives: Dietary Supplement: protein powder supplement |
| Group 3 | Experimental | Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose. Receives: Dietary Supplement: protein powder supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance on Cambridge Cognition tests (CANTAB)
Five tests created by Cambridge Cognition (CANTAB) will be selected and administered at enrollment, halfway through the intervention, and at the end of the intervention. The tests will examine visual memory pattern, recognition memory, test comprehension, rule acquisition, and attention set shifting. These tests will be administered on a Windows tablet by trained research staff. The participants will start by taking a practice test to get use to using the tablet and test format.
Measured: 9 months
Change in height-for-age z score over the period of supplementation.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
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 School Feeding Programs and Nutrition SupplementsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, Arla Foods
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757508
- Sponsor's protocol ID
- HAPFAM
- Status last verified
- Feb 2018
- First submitted
- 20 Apr 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual data available
Publications
Lee R, Singh L, van Liefde D, Callaghan-Gillespie M, Steiner-Asiedu M, Saalia K, Edwards C, Serena A, Hershey T, Manary MJ. Milk Powder Added to a School Meal Increases Cognitive Test Scores in Ghanaian Children. J Nutr. 2018 Jul 1;148(7):1177-1184. doi: 10.1093/jn/nxy083.
PubMed 29905824
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs
- ClinicalTrials.gov ID
- NCT02757508
- Acronym / sponsor ID
- HAPFAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Ghana, Arla Foods
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 2 May 2016 (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.
This study is to gather information on school feeding programs and to measure the effect on linear growth and cognitive performance when providing a high-quality milk protein source or a combination of a high-quality milk protein source and rice proteins as a nutritional supplement to school children in Ghana. Children will receive a meal with a protein powder supplement with vitamins and minerals mixed into it. Participation is expected to last for 9 months.
1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary schools (60 per school). Participants will be randomized to one of four groups: Control: Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF recommendations.
For groups 1-3 the same vitamin/mineral mix will be used along with Group 1. Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.
Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose.
Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.
At baseline measurements-weight,height,mid-upper arm circumference,and body composition will be taken, fasting blood spot test will be administered to measure levels of Insulin and insulin like growth factor and other metabolic test, and computer based cognitive testing. Demographic information will be collected along with a dietary survey. Primary outcomes are cognitive performance on standardized tests and change in height-for-age z-score over the supplementation period, 9 months total. Questionnaires will be administered to collect demographic data and dietary information.
At the mid-point all measurements will be taken again and cognitive testing will be repeated.
At the end of the study all measurements will be taken again, cognitive testing repeated, blood spot samples taken again, and a short survey will be administered about the protein powders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Vitamins/mineralsVitamins/minerals-200 mg premix |
| Group 1 | Experimental | Dietary Supplement: protein powder supplementVitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose. |
| Group 2 | Experimental | Dietary Supplement: protein powder supplementVitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose. |
| Group 3 | Experimental | Dietary Supplement: protein powder supplementVitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ghana school children between the ages of 6-9 years old
Key exclusion criteria (3 listed)
- children with severe malnutrition
- chronic debilitation disease
- milk allergy
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 |
|---|---|---|
| protein powder supplement | Dietary supplement | Group 1, Group 2, Group 3 |
| Vitamins/minerals | Dietary supplement | Control |
Primary outcome
Cognitive performance on Cambridge Cognition tests (CANTAB)
Time frame: 9 months
Five tests created by Cambridge Cognition (CANTAB) will be selected and administered at enrollment, halfway through the intervention, and at the end of the intervention. The tests will examine visual memory pattern, recognition memory, test comprehension, rule acquisition, and attention set shifting. These tests will be administered on a Windows tablet by trained research staff. The participants will start by taking a practice test to get use to using the tablet and test format.
Change in height-for-age z score over the period of supplementation.
Time frame: 9 months
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 13 Feb 2018.
- Derived from this study: PubMed 29905824Lee R, Singh L, van Liefde D, Callaghan-Gillespie M, Steiner-Asiedu M, Saalia K, Edwards C, Serena A, Hershey T, Manary MJ. Milk Powder Added to a School Meal Increases Cognitive Test Scores in Ghanaian Children. J Nutr. 2018 Jul 1;148(7):1177-1184. doi: 10.1093/jn/nxy083.
- Individual participant dataSharing planned: No. There is no plan to make individual data available
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein powder supplement and Vitamins/minerals in people with School Feeding Programs and Nutrition Supplements, run by Washington University School of Medicine at 2 sites in 2 countries.
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 1 inclusion and 3 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ghana. 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. 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?
Cognitive performance on Cambridge Cognition tests (CANTAB) (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT02757508, 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 13 Feb 2018.