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Completed

NCT Number: NCT07585318

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

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.

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Key information

Age range

24 month–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutrition of Central America and Panama (INCAP)

Guatemala City, Departamento de Guatemala, 01011, Guatemala

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

F3 Biofortified Maize

Other

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

Conventional Maize

Other

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

Primary outcomes

  1. Cellular Zinc Status (LA:DGLA Ratio)

    Time frame: 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 outcomes

  1. Iron Status

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

    Hemoglobin and Serum Ferritin levels (adjusted and unadjusted for inflammation)

  2. Systemic Inflammation

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

    Measured via high-sensitivity C-reactive protein (hsCRP)

  3. Gut Microbiota

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

    Characterization of fecal microbiota using 16S rRNA sequencing

  4. Fecal Calprotectin

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

    Measurement of fecal calprotectin as a marker of intestinal inflammation.

  5. Fecal Fatty Acid Profiles

    Time frame: 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.

  6. Nutritional Biomarkers

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

    Serum Vitamin B12 and Serum Albumin levels.

Sponsors and collaborators

Lead sponsor

Institute of Nutrition of Central America and Panama

Other

Registry information

Official study title

Crop-Derived Bioactive Compounds for Improved Gut Health and Nutrition

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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