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

Crop-Derived Bioactive Compounds for Improved Gut Health and Nutrition

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.

Study Overview

• Status: Completed
• Conditions: Zinc Deficiency; Mother and Child Malnutrition
• Intervention / Treatment: Other: F3 Biofortified Maize; Other: Conventional Maize

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Departamento de Guatemala
    • Guatemala City, Departamento de Guatemala, Guatemala, 01011
      • Institute of Nutrition of Central America and Panama (INCAP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F3 Biofortified Maize; 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; Daily consumption of zinc-biofortified maize (F3) for up to 10 months.
Active Comparator: Conventional Maize (Control); 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; Daily consumption of conventional maize for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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))

Secondary Outcome Measures

Outcome Measure	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	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))

Collaborators and Investigators

• Sponsor: Institute of Nutrition of Central America and Panama
• Investigators: Principal Investigator: Elad Tako, PhD, Cornell University; Principal Investigator: Manolo Mazariegos, Institute of Nutrition of Central America and Panama

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Global Health; Biofortified maize; Mother and child nutrition; Zinc and iron deficiency
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Iron Metabolism Disorders; Nutritional and Metabolic Diseases; Iron Deficiencies; Child Nutrition Disorders
• Other Study ID Numbers: 2108010502; CIE-REV 115-2022 (Other Identifier: INCAP Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No