An interventional study of Corn soy bean blended flour porridge plus indispensable amino acid in Amino Acid, Stunting, Environmental Enteric Dysfunction, sponsored by Kamuzu University of Health Sciences. Not yet recruiting at 1 site in Malawi. Open to participants aged 18 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Kamuzu University of Health Sciences · Not applicable, Interventional, and Prevention
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.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
This study's planned enrollment of 66 is below the median of 413 across 143 interventional studies indexed under Growth Disorders.
Browse Growth Disorders studies →Kamuzu University of Health Sciences is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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In order to be eligible to participate in the study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid
Children in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
Dietary Supplement: Corn 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.
corn soy bean flour porridge with added indespensable amino acids
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.
Time frame: 30 days
Corn soy bean flour porridge
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
Time frame: 30 days
Plan to share: Undecided — The Principal Investigator will determine authorship on primary and secondary publications of data derived from this trial and published by the PI's research group. De-identified data will be shared with PI approval beginning 6 months after primary trial publication with researchers that provide reasonable statistical analysis plans.
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Aug 2026, 21 months later.
Of 77 non-industry interventional studies with no phase under Growth Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's planned 21 months is close to that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 12 and three quarters within 30.
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Kamuzu University of Health Sciences