Healthy and Affordable Protein Rich Foods for African Market

Study Overview
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Brief Summary
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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.

Official Title
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Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs

Conditions
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School Feeding Programs and Nutrition Supplements

Intervention / Treatment
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* Dietary Supplement: protein powder supplement
* Dietary Supplement: Vitamins/minerals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ghana school children between the ages of 6-9 years old Exclusion Criteria: children with severe malnutrition chronic debilitation disease milk allergy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Vitamins/minerals-200 mg premix | Dietary Supplement: Vitamins/minerals<br> <br> |
| Experimental: Group 1<br>Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose. | Dietary Supplement: protein powder supplement<br> <br> |
| Experimental: Group 2<br>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. | Dietary Supplement: protein powder supplement<br> <br> |
| Experimental: Group 3<br>Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose. | Dietary Supplement: protein powder supplement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 
| Change in height-for-age z score over the period of supplementation. |  | 9 months |