Nutrition

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    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
    (2022-04-26) Manary, Mark; Maleta, Kenneth
    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.