Healthy and Affordable Protein Rich Foods for African Market

Not Applicable

Completed

• Conditions: School Feeding Programs and Nutrition Supplements
• Interventions: Dietary Supplement: Vitamins/minerals; Dietary Supplement: protein powder supplement

• Registration Number: NCT02757508
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-02
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1041

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Vitamins/minerals	Vitamins/minerals-200 mg premix
Group 1	protein powder supplement	Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.
Group 3	protein powder supplement	Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.
Group 2	protein powder supplement	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.

Primary Outcome Measures

Name	Time	Method
Change in height-for-age z score over the period of supplementation.	9 months
Cognitive performance on Cambridge Cognition tests (CANTAB)	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States