The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds

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.

Study Overview

• Status: Completed
• Conditions: Environmental Enteropathy
• Intervention / Treatment: Dietary supplement: cowpeas complementary food; Dietary supplement: common bean complementary food; Dietary supplement: corn-soy flour

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
• aged 12-35 months
• youngest eligible child in each household

Exclusion Criteria:Unable to drink 20 mL of sugar water

• Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
• Apparent need for acute medical treatment for an illness or injury
• Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cowpeas; Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.	Dietary supplement: cowpeas complementary food; cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Experimental: Common bean; Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.	Dietary supplement: common bean complementary food; common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Active Comparator: Corn Soy Flour; 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.	Dietary supplement: corn-soy flour; Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactulose Excretion	percentage of ingested lactulose excreted in urine	3 months
Lactulose Excretion	percentage of ingested lactulose excreted in urine	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: LG2