Guatemala Biofortified Maize Study

Not Applicable

Recruiting

• Conditions: Zinc Absorption; Iron Absorption

• Registration Number: NCT06650397
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to increase dietary Zn and Fe intake and improve the amount of Zn and Fe absorbed when compared to diets incorporating traditional maize (control). This is a randomized, double blinded, comparison study of biofortified vs control maize prepared as tortillas from nixtamalized masa. This study will enroll up to 56 school aged children (10-14 yrs old) living in agricultural communities in the Western Highlands of Guatemala (28/group x 2 groups). Researchers will utilize Zn and Fe stable isotopes to measure total absorbed Zn and Fe. Participants will be active in the study for 27 days. During this time, they will have anthropometric measurements taken and collect 2 blood samples, 1 stool sample, and 9 urine samples.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-07-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total absorbed iron (TAI) (mg)	2 days	Total absorbed iron from the diet = fractional absorption of iron x total dietary iron (mg)
Total absorbed zinc (TAZ) (mg)	1 day	Total zinc absorbed from the diet = fractional absorption of zinc x total dietary zinc (mg)

Secondary Outcome Measures

Name	Time	Method
Plasma C-reactive protein (CRP) (mg/dL)	1 day	CRP is used to measure systemic inflammation
Plasma zinc concentration (mcg/dL)	1 day	Plasma zinc concentration is used to assess zinc status
Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL)	1 day	AGP is used to measure systemic inflammation

Trial Locations

Locations (1)

Institute of Nutrition of Central America and Panama; 🇬🇹 Guatemala City, Guatemala