Browsing by Author "Maleta, Kenneth"

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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.
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    A two-phase study to investigate novel biomarkers of egg consumption and social marketing effectiveness of egg hubs Malawian infants
    (Kamuzu University of Health Sciences, 2020-06-22) Manary, Mark; Maleta, Kenneth
    Type of Study: :A controlled feeding study with infants and randomized controlled effectiveness trial to evaluate the impact of social marketing on egg consumption among vulnerable Malawian infants. Problem to be studied: A reliable and convenient way to measure the quantity of egg consumed by an individual. Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%. Because there is no reliable way to detect egg consumption, the impact of a social marketing campaign on egg consumption among children in central Malawi in the vicinity of small-scale egg producers is not known. Objective: Identify a novel set of dietary biomarkers that will measure egg consumption, that would be free from participant recall bias, and serve to quantify intake. Utilize novel egg consumption biomarkers to measure egg consumption among infants in communities with social marketing campaigns have been implemented. Methodology:: Phase 1: A total of 25 subjects, children (9-24 months) will consume 2 distinct daily intake dosages of eggs with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the each 5-day period. Urine samples will undergo metabolite detection via ultraperformance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks will be quantified using area-under-the-curve summation and each metabolite will be quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare egg metabolite abundances over time in an individual baseline level. The result of phase 1 will be that the amount of egg consumed will be able to be measured accurately with a urine test. Phase 2: Among eight different “egg hubs”, a cluster of 10 egg farmers, 4 egg hubs will be randomized to receive social marketing and 4 will not receive social marketing. At the onset of the study before social marketing is implemented, and once a month for 8 months, there will be 1 monitoring day per month in the vicinity of each of the 8 different egg hubs. All will be welcomed, especially mothers of children 6-24 months, during this monitoring day, the research staff will provide community education about good complementary feeding practices. Among the children between 6-24 months, up to 25 will recruited to provide some basic demographic and health information, anthropometric measurements, and to give a urine specimen. Urine samples will undergo detection of the novel biomarker from phase 1 to determine egg consumption. Consumption between intervention and control sites will be compared to detect differences in egg consumption at each time point during the intervention. Expected finding: Egg metabolites that serve as exposure markers, and with varied abundance over time from urine. Novel egg biomarkers will provide a non-bias assessment of the effectiveness of social marketing campaign on egg consumption among vulnerable Malawian children. Dissemination of the results: A report of all results will be submitted to the supporting institutions (The College of Medicine – University of Malawi, Washington University School of Medicine) as well as to COMREC and the participating patients that wish to receive the results. The results will further be submitted to a peer-reviewed journal for publication