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临床试验/NCT07585318
NCT07585318已完成不适用

Crop-Derived Bioactive Compounds for Improved Gut Health and Nutrition

Institute of Nutrition of Central America and Panama1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Months 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

F3 Biofortified Maize

Experimental

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).

干预措施: F3 Biofortified Maize (Other)

Conventional Maize (Control)

Active Comparator

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).

干预措施: Conventional Maize (Other)

研究者

发起方
Institute of Nutrition of Central America and Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manolo Mazariegos

Head, Dept. Nutrition and Micronutrients

Institute of Nutrition of Central America and Panama

研究点 (1)

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