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

NCT07585318 | Completed

• 2 other identifiers: 2108010502CIE-REV 115-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Zinc Deficiency; Mother and Child Malnutrition

Keywords

Global Health; Biofortified maize; Mother and child nutrition; Zinc and iron deficiency

Outcome Measures

Primary Outcomes (1)

• 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))

Secondary Outcomes (6)

• Iron Status

  Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))

• Systemic Inflammation

  Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))

• Gut Microbiota

  Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))

• Fecal Calprotectin

  Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))

• Fecal Fatty Acid Profiles

  Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))

Study Arms (2)

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).

Other: F3 Biofortified Maize

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).

Other: Conventional Maize

Interventions

F3 Biofortified Maize OTHER

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

F3 Biofortified Maize

Conventional Maize OTHER

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

Conventional Maize (Control)

Eligibility Criteria

• Age: 24 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Nutrition of Central America and Panama: lead

Study Sites (1)

Institute of Nutrition of Central America and Panama (INCAP)

Guatemala City, Departamento de Guatemala, 01011, Guatemala

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Iron Deficiencies

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• Elad Tako, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Manolo Mazariegos

  Institute of Nutrition of Central America and Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept. Nutrition and Micronutrients

Model Details: A longitudinal two arm study, one group consuming zinc biofortified maize and one group, conventional maize.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: March 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: 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.

Locations

GU (1)