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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02472301

Enrollment

337

Registered

2015-06-15

Start date

2015-08-31

Completion date

2016-12-31

Last updated

2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Enteropathy

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTcowpeas complementary food

cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

DIETARY_SUPPLEMENTcorn-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.

DIETARY_SUPPLEMENTcommon 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Months to 35 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Dual Sugar Absorption Test	3 months	lactulose-mannitol ratio in urine

Secondary

Measure	Time frame	Description
Lactulose Excretion	3 months	percentage of ingested lactulose excreted in urine
Mannitol Excretion	3 months	percentage of ingested mannitol excreted in urine

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026