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Healthy and Affordable Protein Rich Foods for African Market

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02757508
Enrollment
1041
Registered
2016-05-02
Start date
2016-03-01
Completion date
2017-07-30
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

School Feeding Programs and Nutrition Supplements

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.

Interventions

DIETARY_SUPPLEMENTprotein powder supplement
DIETARY_SUPPLEMENTVitamins/minerals

Sponsors

University of Ghana
CollaboratorOTHER
Arla Foods
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive performance on Cambridge Cognition tests (CANTAB)9 monthsFive 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.9 months

Countries

Ghana, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026