Clinical trial NCT02757508: Healthy and Affordable Protein Rich Foods for African Market
Official title: Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Feeding Programs and Nutrition Supplements
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: Arla Foods
First posted: 2016-05-02
Enrollment: 1041
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Ghana school children between the ages of 6-9 years old

Exclusion Criteria:

* children with severe malnutrition
* chronic debilitation disease
* milk allergy

Primary outcomes:
measure: Cognitive performance on Cambridge Cognition tests (CANTAB)
timeFrame: 9 months
measure: Change in height-for-age z score over the period of supplementation.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Atebubu
country: Ghana
Study officials:
References:
citation: 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.