Mother and Child Malnutrition, Zinc Deficiency
Conditions
Keywords
Global Health, Biofortified maize, Mother and child nutrition, Zinc and iron deficiency
Brief summary
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.
Detailed description
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.
Interventions
OTHERF3 Biofortified Maize
Daily consumption of zinc-biofortified maize (F3) for up to 10 months.
OTHERConventional Maize
Daily consumption of conventional maize for the duration of the study.
Sponsors
Institute of Nutrition of Central America and Panama
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A longitudinal two arm study, one group consuming zinc biofortified maize and one group, conventional maize.
Eligibility
Sex/Gender
ALL
Age
24 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Household Inclusion Criteria: * Reside in the target area (Chiquimula Department, Guatemala); * Participating in the World Vision (WV) nutrition program; * Families accustomed to consuming maize; * Interest to participate in an informative session; * Presence of at least one woman of reproductive age (18-49 years) and one index child (12-59 months); * Access to a mobile phone; (7) No concurrent participation in other nutrition or food aid programs. Household
Exclusion criteria
* Women with problems understanding the study informed consent and the study survey; * Women with any acute or chronic disease that affected dietary intake or nutritional status; * Children with acute malnutrition 4.Children with any acute or chronic disease that affected dietary consumption or nutritional status; * Households that failed to adhere to the study protocol during the previous intervention period (e.g., sold the study maize or diverted it for animal feed).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Zinc Status (LA:DGLA Ratio) | Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment)) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron Status | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Hemoglobin and Serum Ferritin levels (adjusted and unadjusted for inflammation) |
| Systemic Inflammation | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Measured via high-sensitivity C-reactive protein (hsCRP) |
| Gut Microbiota | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Characterization of fecal microbiota using 16S rRNA sequencing |
| Fecal Calprotectin | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Measurement of fecal calprotectin as a marker of intestinal inflammation. |
| Fecal Fatty Acid Profiles | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Quantification of short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) in stool samples. |
| Nutritional Biomarkers | Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment)) | Serum Vitamin B12 and Serum Albumin levels. |
Countries
Guatemala
Contacts
PRINCIPAL_INVESTIGATORElad Tako, PhD
Cornell University
PRINCIPAL_INVESTIGATORManolo Mazariegos
Institute of Nutrition of Central America and Panama
Outcome results
None listed