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| ID | Type | Description | Link |
|---|---|---|---|
| CIE-REV 115-2022 | Other Identifier | INCAP Ethics Committee |
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A trial evaluating the systemic and ecological impact of zinc-biofortified maize consumption on cellular zinc status, inflammatory biomarkers, and gut microbiota composition in a cohort of Guatemalan mothers and children.
This is a pilot study conducted among a subset of participants in a larger food aid intervention program using biofortified maize (N=499). This analysis focuses on a highly compliant cohort of 30 households (N=60 individuals) providing high-fidelity multi-omic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F3 Biofortified Maize | Experimental | 16 households (mothers and children) received zinc-biofortified maize seed (F3) for planting and maize consumption as part of their daily diet (Phase I). Due to implementation challenges (harvest failure due to drougth), the intervention was changed to delivery to zinc-biofortified maize grain for consumption (Phase II). |
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| Conventional Maize (Control) | Active Comparator | 14 households (mothers and children) planted regular maize (Phase I). Due to implementation challenges (harvest failure due to drougth), the intervention was changed to delivery of regular maize grain for consumption (Phase II). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F3 Biofortified Maize | Other | Daily consumption of zinc-biofortified maize (F3) for up to 10 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cellular Zinc Status (LA:DGLA Ratio) | Physiological zinc status measured via red blood cell (RBC) long-chain fatty acid analysis, specifically the linoleic acid to dihomo-gamma-linolenic acid (LA:DGLA) ratio | Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment)) |
| Measure | Description | Time Frame |
|---|---|---|
| Iron Status | Hemoglobin and Serum Ferritin levels (adjusted and unadjusted for inflammation) | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |
| Systemic Inflammation |
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Household Inclusion Criteria:
Household exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elad Tako, PhD | Cornell University | Principal Investigator |
| Manolo Mazariegos | Institute of Nutrition of Central America and Panama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition of Central America and Panama (INCAP) | Guatemala City | Departamento de Guatemala | 01011 | Guatemala |
De-identified individual participant data that underlie the results reported in this article (including microbiome sequencing metadata and nutritional biomarkers) will be made available to researchers who provide a methodologically sound proposal.
Beginning 6 months and ending 5 years following article publication.
Data will be available upon request to the corresponding author (Prof. Elad Tako) to ensure the proposed use is consistent with the original informed consent and ethical approvals.
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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A longitudinal two arm study, one group consuming zinc biofortified maize and one group, conventional maize.
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| Conventional Maize | Other | Daily consumption of conventional maize for the duration of the study. |
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Measured via high-sensitivity C-reactive protein (hsCRP)
| Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |
| Gut Microbiota | Characterization of fecal microbiota using 16S rRNA sequencing | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |
| Fecal Calprotectin | Measurement of fecal calprotectin as a marker of intestinal inflammation. | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |
| Fecal Fatty Acid Profiles | Quantification of short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) in stool samples. | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |
| Nutritional Biomarkers | Serum Vitamin B12 and Serum Albumin levels. | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) |