Multi-Omic Profiling of a Zinc-Biofortified Maize Intervention in Guatemalan Mothers and Children

Institute of Nutrition of Central America and Panama60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Zinc Deficiency Mother and Child Malnutrition

Interventions

F3 Biofortified MaizeOTHER

Daily consumption of zinc-biofortified maize (F3) for up to 10 months.

Conventional MaizeOTHER

Daily consumption of conventional maize for the duration of the study.

Eligibility

Sex: ALLMin age: 24 MonthsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Institute of Nutrition of Central America and Panama (INCAP)

Guatemala City, Departamento de Guatemala, Guatemala

Outcomes

Primary Outcomes

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

Time frame: Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment))