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| Name | Class |
|---|---|
| International Atomic Energy Agency | OTHER_GOV |
| University of Glasgow | OTHER |
| Ghana Atomic Energy Commission | UNKNOWN |
| Kamuzu University of Health Sciences |
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The goal of this intervention study is to determine the effects of indispensable amino acid (IAA) supplementation on children of either sex, aged 18 to 36 months. The main questions it aims to answer are:
The researchers will compare the effects of consumption of standard complementary food with added IAA against a control group that has no added IAA through the assessment of the various biomarkers.
Participants will:
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive the standard complementary foods (in the control group) or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (in the intervention group).
Standard complementary foods will be comprised of ingredients mainly of rice and legumes. Standard complementary foods are foods that meet the dietary needs of children 6-36 months of age.
At least three observed (controlled) feeding sessions per week will be conducted over the 4 weeks of the study to confirm that the entire supplement was consumed or confirm intake. The observed feeding will take place at the child's home or at the barangay center. Uptake on non-observed days will be based on the caregiver's report. On each intervention monitoring day, a questionnaire will also be administered to assess child morbidity that day and on the day prior. A pediatrician or an alternate medical practitioner will also be invited during the data collection where in stable isotopes will be administered. The duties and responsibilities of the physician include: medical assessment of the participant, assistance in the collection of blood samples, assessment of adverse events (if any), and provision of first aid (if needed).
In the absence of treatment delays due to adverse events, the intervention will continue for 1 month or until one of the following criteria apply:
For each participant, tests to be conducted at study enrolment will be spread over three days. At the end of the study, endline tests will be spread over 2 days. Baseline visits for breath, blood, urine, and fecal collection should be conducted within -3 days prior to study treatment (day 3) while endline visits should be conducted within +7 days of study treatment (day 31). The intervention will be provided in coded sachets, distributed as per convenient for local custom to best ensure compliance with a minimum of three supervised feeds per week to ensure supplement is consumed at least periodically by the child and also to assess compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | complementary food supplemented with indispensable amino acid (IAA) mix |
|
| Control Group | Experimental | complementary food without IAA mix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IAA mix supplement | Dietary Supplement | The intervention is a daily IAA dose that provides x1.5 the estimated average requirement (EAR) for a healthy child. This IAA dose will be mixed to the complementary food and will be taken once daily for 4 weeks (28 days) by the child in the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days | Baseline and end of intervention at 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Protein Absorption as Assessed by the Dual Stable Isotope Tracer (DSIT) Technique at 28 days | Baseline and end of intervention at 28 days | |
| Change from Baseline in Gut Digestive Capacity Measured by the 13C-Sucrose Breath Test (SBT) at 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Length-for-age z-score (LAZ) at 28 Days and 6 Months | Baseline and end of intervention at 28 days and follow-up after 6 months | |
| Change from Baseline in Weight at 28 days | Baseline and end of intervention at 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amster Fei P. Baquiran, BS Chemistry | Contact | +632 8837 8113 | 341 | afpbaquiran@gmail.com |
| Carl Vincent D. Cabanilla, BS Chemistry | Contact | +632 8837 8113 | 307 | cvdcabanilla@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amster Fei P. Baquiran, BS Chemistry | Department of Science and Technology Food and Nutrition Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Science and Technology - Food and Nutrition Research Institute | City of Taguig | National Capital Region | 1631 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36870290 | Background | Abtahi S, Sailer A, Roland JT, Haest X, Chanez-Paredes SD, Ahmad K, Sadiq K, Iqbal NT, Ali SA, Turner JR. Intestinal Epithelial Digestive, Transport, and Barrier Protein Expression Is Increased in Environmental Enteric Dysfunction. Lab Invest. 2023 Apr;103(4):100036. doi: 10.1016/j.labinv.2022.100036. Epub 2023 Jan 10. | |
| 32611463 |
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| University of Zambia | OTHER |
| Rutgers, The State University of New Jersey | OTHER |
| St. John's Research Institute | OTHER |
| cnesten, Morocco | UNKNOWN |
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|
| Complementary food comprised of rice and legumes | Other | Each study child will receive standard complementary food which he/she will take once daily for 4 weeks (28 days) |
|
| Baseline and end of intervention at 28 days |
| Change from Baseline in Gut Function Based on Plasma LPS-Binding Protein (LPSBP) Concentration at 28 days | Baseline and end of intervention at 28 days |
| Change from Baseline in Gut Function Based on Intestinal Fatty Acid Binding Protein (iFABP) Concentration at 28 days | Baseline and end of intervention at 28 days |
| Change from Baseline in Gut Inflammation Based on Fecal Myeloperoxidase Concentration at 28 days | Baseline and end of intervention at 28 days |
| Change from Baseline in Gut Inflammation Based on Fecal Neopterin Concentration at 28 days | Baseline and end of intervention at 28 days |
| Change from Baseline in Body Composition in 6 months | Baseline and follow-up after 6 months |
| Correlation Between Gut Microbiota Composition and Plasma Biomarkers of Gut Function (LPSBP and iFABP) | Baseline, pre-intervention |
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