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OpenTrials
Completed

NCT Number: NCT02757508

Healthy and Affordable Protein Rich Foods for African Market

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atebubu, Ghana

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

protein powder supplement

Dietary Supplement

Vitamins/minerals

Dietary Supplement

Primary outcomes

  1. Cognitive performance on Cambridge Cognition tests (CANTAB)

    Time frame: 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.

  2. Change in height-for-age z score over the period of supplementation.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Arla Foods
  • University of Ghana

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.