School Feeding Programs and Nutrition Supplements Clinical Trial
Official title:
Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs
| Verified date | February 2018 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1041 |
| Est. completion date | July 30, 2017 |
| Est. primary completion date | July 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Years to 9 Years |
| Eligibility |
Inclusion Criteria: - Ghana school children between the ages of 6-9 years old Exclusion Criteria: - children with severe malnutrition - chronic debilitation disease - milk allergy |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine | Arla Foods, University of Ghana |
United States, Ghana,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Change in height-for-age z score over the period of supplementation. | 9 months |