CClinicalTrials.gg
Sign In
CompletedNCT02472262Updated Dec 2, 2019Results posted

The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months

An interventional study of Cow pea complementary food and Corn soy flour in Enteropathy, sponsored by Washington University School of Medicine. Completed at 1 site in Malawi. Open to participants aged 5 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
355
Allocation
Randomized
Ages
5 Months to 12 Months
Sex
All
01

Study summary

To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months to see if these improvements are correlated with specific changes in the enteric microbiome.

02

Conditions studied

  • Enteropathy

Browse trials for

Keywords

  • Environmental
  • Enteric
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 355 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

children residing in catchment area of Limela, Machinga District and Ntenda (Chikwawa District), Malawi aged 6-11 months youngest eligible child in each household

Exclusion criteria

-

Exclusion Criteria:

Unable to drink 20 mL of sugar water Demonstrating evidence of severe acute malnutrition Apparent need for acute medical treatment for an illness or injury Caregiver refusal to participate and return for 3 and 6 month follow-ups -

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
355 participants (actual)

Study arms

  • Experimental
    Cow pea complementary food

    A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

    Dietary Supplement: Cow pea complementary food

  • Experimental
    Common bean

    A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

    Dietary Supplement: Common bean

  • Active comparator
    Corn Soy Flour

    Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

    Dietary Supplement: Corn soy flour

Interventions

  • Dietary supplementCow pea complementary food

    A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

  • Dietary supplementCorn soy flour

    Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

  • Dietary supplementCommon bean

    A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

06

What researchers measure

Primary outcomes

  1. Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.

    Change in length-for-age z score from enrollment to end of study 6 months

    Time frame: 6 months

  2. % Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age

    percent of lactulose found in urine during the dual sugar absorption test

    Time frame: 6 month

Secondary outcomes

  1. 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups

    Time frame: 6 months

  2. Mid-upper Arm Circumference at 9 and 12 Months of Age

    Mid-upper arm circumference in cm

    Time frame: 6 months

  3. Weight-for-height z Score at 9 and 12 Months of Age

    weight for height z-score at 9 and 12 months of age

    Time frame: 6 months

  4. Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population

    Time frame: 6 months

07

Results

Posted Nov 13, 2019

Participant flow

Participant flow — Overall Study
MilestoneCow Pea Complementary FoodCommon BeanCorn Soy Flour
Started117120118
Completed999993
Not completed182125

Outcome measures

PrimaryChange in Length-for-age z Score Over 6 Months From Enrollment to End of Study.

Change in length-for-age z score from enrollment to end of study 6 months

Time frame:
6 months
Reported as:
Mean · z-score
Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.
z-scoreCow Pea Complementary FoodCommon BeanCorn Soy Flour
Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.-0.14 (-0.24 to -0.04)-0.27 (-0.38 to -0.16)-0.27 (-0.35 to -0.19)
Primary% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age

percent of lactulose found in urine during the dual sugar absorption test

Time frame:
6 month

Results for this outcome have not been posted.

Secondary16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups
Time frame:
6 months

Results for this outcome have not been posted.

SecondaryMid-upper Arm Circumference at 9 and 12 Months of Age

Mid-upper arm circumference in cm

Time frame:
6 months

Results for this outcome have not been posted.

SecondaryWeight-for-height z Score at 9 and 12 Months of Age

weight for height z-score at 9 and 12 months of age

Time frame:
6 months

Results for this outcome have not been posted.

SecondaryAssociation of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population
Time frame:
6 months

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cow Pea Complementary Food—0/117 (0%)0/117 (0%)
Common Bean—0/120 (0%)0/120 (0%)
Corn Soy Flour—0/118 (0%)0/118 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cow Pea Complementary FoodCommon BeanCorn Soy FlourTotal
<=18 years117120118355
Between 18 and 65 years0000
>=65 years0000
Age, Continuous
Age, Continuous(months)Cow Pea Complementary FoodCommon BeanCorn Soy FlourTotal
Mean5.8 ± 0.35.8 ± 0.35.8 ± 0.45.8 ± 0.3
Sex: Female, Male
Sex: Female, Male(Participants)Cow Pea Complementary FoodCommon BeanCorn Soy FlourTotal
Female596053172
Male586065183
Region of Enrollment
Region of Enrollment(participants)Cow Pea Complementary FoodCommon BeanCorn Soy FlourTotal
Malawi117120118355
08

Study locations

1 site
  • University of Malawi
    Blantyre, Malawi
09

References and documents

Publications

  • Ordiz MI, Janssen S, Humphrey G, Ackermann G, Stephenson K, Agapova S, Divala O, Kaimila Y, Maleta K, Zhong C, Knight R, Trehan I, Tarr PI, Rusconi B, Manary MJ. The effect of legume supplementation on the gut microbiota in rural Malawian infants aged 6 to 12 months. Am J Clin Nutr. 2020 Apr 1;111(4):884-892. doi: 10.1093/ajcn/nqaa011. PubMed 32047925 ↗
  • Ordiz MI, Semba RD, Moaddel R, Rolle-Kampczyk U, von Bergen M, Herberth G, Khadeer M, Roder S, Manary MJ. Serum Amino Acid Concentrations in Infants from Malawi are Associated with Linear Growth. Curr Dev Nutr. 2019 Aug 29;3(10):nzz100. doi: 10.1093/cdn/nzz100. eCollection 2019 Oct. PubMed 31620672 ↗
  • 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. PubMed 31022095 ↗
  • 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. PubMed 29955682 ↗
  • Stephenson KB, Agapova SE, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial. Am J Clin Nutr. 2017 Dec;106(6):1500-1507. doi: 10.3945/ajcn.117.160986. Epub 2017 Nov 1. PubMed 29092882 ↗
  • 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. PubMed 26578308 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02472262
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Jun 15, 2015
Start date
Aug 2015
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Nov 13, 2019
Last update
Dec 2, 2019

Study contacts

Mark Manary, MD
principal investigator · Washington University School of Medince

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Intestinal Diseases→

Other studies from this sponsor

Washington University School of Medicine

Start the discussion