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临床试验/NCT03412825
NCT03412825已完成不适用

The Effect of Dietary Supplementation on Nutrient Status in Families Living in a Food Insecure Environment

University of Arkansas, Fayetteville2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12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
入组人数
50
试验地点
2
主要终点
Body composition

研究概览

简要总结

Arkansas has one of the highest rates for food insecurity and 27.7% of children in the University of Arkansas area are food insecure. In addition, more than 14% of children ages 2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area surrounding the University of Arkansas in Fayetteville (Washington County), the food insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity, and food insecurity (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Food insecurity assessed by use of SNAP benefits or qualifying using the US Food Security Scale).

排除标准

  • No dietary restrictions
  • Fear of needles
  • Metabolic disorders
  • Picky eating
  • Taking medication

研究组 & 干预措施

Control

No Intervention

Nutrition Supplementation

Experimental

干预措施: Egg supplementation (Dietary Supplement)

结局指标

主要结局

Body composition

时间窗: The change in body composition (e.g. ratio of lean to fat mass) will measured from baseline to 16 weeks.

Body composition will be measured using dual X-ray absorptiometry (DEXA) .

Micronutrient status in plasma

时间窗: The change in micronutrient status (e.g. iron, vitamin A, vitamin B12) will be measured from baseline to 16 weeks to determine if the dietary intervention improves baseline micronutrient status.

Micronutrients status will be measured using plasma samples.

次要结局

  • Height(The change in height will be measured from baseline to 16 weeks.)
  • Waist-to-hip ratio(The change in waist-to-hip ratio will be measured from baseline to 16 weeks.)
  • Weight(The change in weight will be measured from baseline to 16 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Baum

Assistant Professor

University of Arkansas, Fayetteville

研究点 (2)

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