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NCT02757508 · ClinicalTrials.gov registry record · NA
Healthy and Affordable Protein Rich Foods for African Market
A NA study of School Feeding Programs and Nutrition Supplements, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 1,041
- Enrollment target
- 2
- Study locations
NCT02757508 is a NA study of School Feeding Programs and Nutrition Supplements that has completed, run by Washington University School of Medicine. The registered enrollment target is 1,041 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT02757508, a NA study of School Feeding Programs and Nutrition Supplements, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,041 participants
- Enrollment target
- 2
- Study locations
Study 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, bloo
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT protein powder supplement
- DIETARY_SUPPLEMENT Vitamins/minerals
Study Locations (2)
Missouri
- Washington University School of Medicine - St Louis
Other
- - Atebubu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,041 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2017-07-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02757508
The ClinicalTrials.gov registry entry for NCT02757508 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,041 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with School Feeding Programs and Nutrition Supplements appearing as the primary indexed condition, and to 2 interventions - of which protein powder supplement is the first listed.
NCT02757508 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, Other.
Frequently Asked Questions
What is clinical trial NCT02757508 about?
NCT02757508 is a clinical study titled "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 childre...
What is the current status of trial NCT02757508?
This trial is currently completed. It is a NA study. The enrollment target is 1,041 participants. The study started on 2016-03-01. Estimated completion is 2017-07-30.
What conditions does trial NCT02757508 study?
This clinical trial studies the following conditions: School Feeding Programs and Nutrition Supplements.
What interventions are being tested in trial NCT02757508?
The interventions under investigation include: protein powder supplement (DIETARY_SUPPLEMENT), Vitamins/minerals (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02757508?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02757508 being conducted?
This trial has 2 study locations across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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