Amino Acid, Stunting, Environmental Enteric Dysfunction
Conditions
Brief summary
A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36 months with or without stunting.
Interventions
DIETARY_SUPPLEMENTCorn soy bean blended flour porridge plus indispensable amino acid
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive corn-soy bean blended flour porridge supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) dosed at 12g/d and providing 1.5 times the estimated average requirement (EAR) for a healthy child (Intervention group). The porridge will provide 30% daily energy requirement. The study foods will be taken once daily by the child with at least three observed feeding sessions per week over the 4 weeks of the study to assess compliance. Children in the control arm will receive corn-soy blended flour porridge without added amino acids.
Sponsors
University of Glasgow
Kamuzu University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
We hypothesize that adding 12 mg/day of indispensable amino acids (IAA) to corn-soy blend blended flour porridge will reduce gut permeability amongst 6-36 month old rural Malawian children at risk of stunting compared to providing only corn-soy blended flour porridge without addition of indispensable amino acids for a period of 4 weeks. This will be a randomized, controlled open label parallel group efficacy clinical trial. Eligible children will be identified through a Demographic Surveillance System implemented by the study group at Mangochi district hospital. 66 children meeting set criteria will be randomised to receive corn-soy blended flour porridge (control group) or corn-soy blended flour porridge to which is added indispensable amino acids. The standard complementary food will provide 30% daily energy requirement while the amino acids in the intervention group will provide 1.5 times the estimated average requirement (EAR) for a healthy child.
Eligibility
Sex/Gender
ALL
Age
18 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
* All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/
Exclusion criteria
assessment, consent, and randomization. In order to be eligible to participate in the study, an individual must meet all of the following criteria: 1. 18-36 months old (now agreed to by all countries) 2. Stunted (LAZ<-2) 3. Of either sex 4. Able and willing to undergo HIV testing 5. Parent, carer, or guardian able and willing to give written, informed consent 6. A positive HIV test result will not be an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| corn soy bean flour porridge with added indespensable amino acids | 30 days | Primary Efficacy Endpoint: We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting will reduce gut permeability as measured by the Lactulose:Rhamonse ratio test when provided over 30 days compared to corn-soy blended flour porridge without added IAA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corn soy bean flour porridge | 30 days | We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting when provided over 30 days compared to corn-soy blended flour porridge without added IAA will: 1. Increase gut digestive capacity 2. Increase plasma protein absorption 3. Reduce gut bacterial translocation 4. Reduce gut bacterial damage 5. Increase child weight 6. Increase plasma circulating amino acids 7. Increase gut microbial abundance and diversity 8. Increase fat free mass index and fat free percentage |
Countries
Malawi
Outcome results
None listed