Randomized, single-blinded, prospective clinical trials comparing the impact of legumes vs corn-soy flour on environmental enteric dysfunction and stunting in rural Malawian children 12-23 months old
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Date
2022-04-26
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Abstract
Executive Summary:
Type of study: Randomized, investigator-blinded, prospective clinical trial
Problem to be studied: Environmental enteric dysfunction (EED) and stunting in children
Objective: Evaluate the effectiveness of two different legume foods (cowpeas and common beans) in
maintaining and/or restoring normal gut absorptive and immunological function in rural Malawian
children at high risk for EED and stunting during their second to third years of life.
Methodology: A prospective randomized, investigator-blinded prospective clinical trials will be used to
evaluate whether supplementary feeding with cowpeas or common beans improves biomarkers of EED,
growth parameters, and the health of the intestinal microbiome.
300 healthy children aged 12-23 months will be equally randomized to receive a legume-based
complementary food made from cowpeas (first intervention group), common beans (second intervention
group), or an isoenergentic amount of corn flour with 10% soy (control group), a traditional Malawian
complementary food. The energy content of the complementary foods provided will be in accordancewith WHO specifications [1], approximately 15% of the estimated total daily intake. Before the
complementary foods are given, the children will participate in a dual sugar permeability test at a
designated village healthcare center and give stool samples for additional biomarker tests to measure gut
function and also to evaluate the evolution of the enteric microbiome while receiving the assigned
complementary food. The dual sugar permeability test (the lactulose-rhamnose test) involves drinking 20
mL of a sugar water solution and collecting urine for 4 hours thereafter. Dietary intake will be assessed
every 6 weeks. Children will return 12, 24, 36, and 48 weeks after starting the intervention for postintervention
assessments, including the dual sugar absorption test, stool collection, and anthropometric
measurements.
Primary outcomes for the study will be: 1) a standard marker of EED, specifically changes in the urinary
lactulose:rhamnose ratio (L:R) during the course of the interventions; 2) a standard marker of growth, the
change in height-for-age Z-score. The secondary outcomes will include the amounts of lactulose and
rhamnose excreted in the urine as a percentage of the amount ingested before and after the intervention.
Additional secondary outcomes will be adverse gastrointestinal symptoms, as well as changes in the
enteric microbiome, stool biomarkers of EED: IL-8, IL-17A, CD-3, Reg 1A, calprotectin, and zonulin,
and investigation of potential novel biomarkers of EED through host transcriptomic analysis of stool
samples.
Expected findings and their dissemination: It is expected that children receiving the legume-based
complementary foods will have improvements in their dual sugar permeability testing and immunoinflammation
biomarkers in comparison with the group receiving standard corn-soy flour, indicating that
their EED has improved. Results will be shared with participants and the sponsoring institutions, as well
as submitted for publication in a peer-reviewed journal.
The purpose of re-submitting this protocol is to allow for continued storage as well as application of an
improved methodology for an original secondary objective, investigation of stool biomarkers of EED by
transcriptomic analysis. We propose to attempt re-consent of participants.
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Nutrition