Multi-Omic Profiling of a Zinc-Biofortified Maize Intervention in Guatemalan Mothers and Children
2026年5月20日 更新者：Manolo Mazariegos、Institute of Nutrition of Central America and Panama
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Departamento de Guatemala
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Guatemala City、Departamento de Guatemala、危地马拉、01011
- Institute of Nutrition of Central America And Panama (INCAP)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
是的
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
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Daily consumption of zinc-biofortified maize (F3) for up to 10 months.
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有源比较器：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).
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Daily consumption of conventional maize for the duration of the study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cellular Zinc Status (LA:DGLA Ratio)
大体时间：Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment))
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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
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Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment))
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Iron Status
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Hemoglobin and Serum Ferritin levels (adjusted and unadjusted for inflammation)
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Systemic Inflammation
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Measured via high-sensitivity C-reactive protein (hsCRP)
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Gut Microbiota
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Characterization of fecal microbiota using 16S rRNA sequencing
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Fecal Calprotectin
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Measurement of fecal calprotectin as a marker of intestinal inflammation.
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Fecal Fatty Acid Profiles
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Quantification of short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) in stool samples.
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Nutritional Biomarkers
大体时间：Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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Serum Vitamin B12 and Serum Albumin levels.
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Up to 10 months (September 2022 (baseline) thru August 2023 (final assessment))
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elad Tako, PhD、Cornell University
- 首席研究员：Manolo Mazariegos、Institute of Nutrition of Central America and Panama
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年3月1日
初级完成 (实际的)
2023年8月31日
研究完成 (实际的)
2023年8月31日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月7日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 2108010502
- CIE-REV 115-2022 (其他标识符：INCAP Ethics Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
Beginning 6 months and ending 5 years following article publication.
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.