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Zinc DeficiencyNCT07585318

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

A study testing F3 Biofortified Maize and Conventional Maize in people with Zinc Deficiency and Mother and Child Malnutrition, run by Institute of Nutrition of Central America and Panama at 1 site in Guatemala.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 months to 49 yearsHealthy volunteers can take part
What is being tested?
F3 Biofortified Maize and Conventional Maize
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGuatemala
Study dates
1 Mar 2022to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 months to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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).

Trial locations and contacts

1 site in 1 country.

Guatemala1 site

  • Institute of Nutrition of Central America and Panama (INCAP)

    Guatemala City, Departamento de Guatemala, 01011

Other trials in Guatemala

About this study

Official title: 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.

Read the 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.

Being tested
F3 Biofortified Maize, Conventional Maize
Keywords
Global Health, Biofortified maize, Mother and child nutrition, Zinc and iron deficiency
Medical subject headings
Child Nutrition Disorders, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07585318
Study groupRoleWhat they receive
F3 Biofortified MaizeExperimental16 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).
Receives: Other: F3 Biofortified Maize
Conventional Maize (Control)Active comparator14 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).
Receives: Other: Conventional Maize

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

  1. Iron Status

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

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

  2. Systemic Inflammation

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

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

  3. Gut Microbiota

    Characterization of fecal microbiota using 16S rRNA sequencing

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

  4. Fecal Calprotectin

    Measurement of fecal calprotectin as a marker of intestinal inflammation.

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

  5. Fecal Fatty Acid Profiles

    Quantification of short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) in stool samples.

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

  6. Nutritional Biomarkers

    Serum Vitamin B12 and Serum Albumin levels.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start1 Mar 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A longitudinal two arm study, one group consuming zinc biofortified maize and one group, conventional maize.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585318
Sponsor's protocol ID
2108010502
Other IDs
CIE-REV 115-2022
Status last verified
May 2026
First submitted
7 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing F3 Biofortified Maize and Conventional Maize in people with Zinc Deficiency and Mother and Child Malnutrition, run by Institute of Nutrition of Central America and Panama at 1 site in Guatemala.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cellular Zinc Status (LA:DGLA Ratio) (time frame: Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07585318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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