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To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cowpeas | Experimental | Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
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| Common bean | Experimental | Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
|
| Corn Soy Flour | Active Comparator | Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cowpeas complementary food | Dietary Supplement | cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 3 months |
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 6 months |
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 3 months |
| Lactulose Excretion | percentage of ingested lactulose excreted in urine |
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Inclusion Criteria:
Exclusion Criteria:Unable to drink 20 mL of sugar water
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| Name | Affiliation | Role |
|---|---|---|
| Mark Manary, MD | Washington University School of Medince | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31022095 | Derived | Kaimila Y, Pitman RT, Divala O, Hendrixson DT, Stephenson KB, Agapova S, Trehan I, Maleta K, Manary MJ. Development of Acute Malnutrition Despite Nutritional Supplementation in Malawi. J Pediatr Gastroenterol Nutr. 2019 May;68(5):734-737. doi: 10.1097/MPG.0000000000002241. | |
| 29955682 | Derived | Borresen EC, Zhang L, Trehan I, Nealon NJ, Maleta KM, Manary MJ, Ryan EP. The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. Curr Dev Nutr. 2017 Sep 21;1(10):e001610. doi: 10.3945/cdn.117.001610. eCollection 2017 Oct. |
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| corn-soy flour | Dietary Supplement | Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
|
| common bean complementary food | Dietary Supplement | common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
|
| 6 months |
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 12 months |
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 3 months |
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 6 months |
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 12 months |
| 29490090 | Derived | Agapova SE, Stephenson KB, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Additional Common Bean in the Diet of Malawian Children Does Not Affect Linear Growth, but Reduces Intestinal Permeability. J Nutr. 2018 Feb 1;148(2):267-274. doi: 10.1093/jn/nxx013. |
| 26578308 | Derived | Trehan I, Benzoni NS, Wang AZ, Bollinger LB, Ngoma TN, Chimimba UK, Stephenson KB, Agapova SE, Maleta KM, Manary MJ. Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials. Trials. 2015 Nov 14;16:520. doi: 10.1186/s13063-015-1027-0. |