Institute of Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, 01011, Guatemala
NCT Number: NCT07585318
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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Notify Me24 month–49 year
All sexes
Interventional
Not applicable
Guatemala City, Departamento de Guatemala, 01011, Guatemala
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Household Inclusion Criteria:
Household exclusion Criteria:
Daily consumption of zinc-biofortified maize (F3) for up to 10 months.
Daily consumption of conventional maize for the duration of the study.
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
Time frame: Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
Hemoglobin and Serum Ferritin levels (adjusted and unadjusted for inflammation)
Time frame: Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
Measured via high-sensitivity C-reactive protein (hsCRP)
Time frame: Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
Characterization of fecal microbiota using 16S rRNA sequencing
Time frame: Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
Measurement of fecal calprotectin as a marker of intestinal inflammation.
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.
Time frame: Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
Serum Vitamin B12 and Serum Albumin levels.
Institute of Nutrition of Central America and Panama
Other
Crop-Derived Bioactive Compounds for Improved Gut Health and Nutrition
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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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