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临床试验/NCT04103294
NCT04103294已完成不适用

Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年7月25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
47
试验地点
1
主要终点
Metabolomic profiling of Urine and Plasma

研究概览

简要总结

Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%.A reliable and convenient way to measure the quantity of cowpea consumed by an individual. The hope is to identify a novel set of dietary biomarkers that will measure cowpea consumption, be free from participant recall bias, and serve to quantify legume intake. A total of 40 subjects, 20 children (9-21 months) and 20 pregnant women (>18 yr) will consume 3 distinct daily intake dosages of cooked cowpeas with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the final 5-day period. Urine samples will undergo metabolite detection via ultra-performance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks are quantified using area-under-the-curve (AUC) and each metabolite is quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare cowpea metabolite abundances over time and with respect to variation in an individual baseline levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
9 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy children between the ages of 9-21 months and pregnant women > 18 years of age and between 20-25 weeks of gestation.

排除标准

  • Children with acute malnutrition, congenital abnormalities, chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection. For the pregnant women they should also be free from acute malnutrition, without known complications such as gestational diabetes, pre-eclampsia, gestational diabetes, or hypertension

研究组 & 干预措施

cowpea variety #1

Experimental

25g of cowpea daily for days 6-10, 50g of cowpea daily for days 11-15 and then 75g of cowpea daily for days 16-20. The pregnant women will receive 50g of cowpea daily for days 6-10, 100g of cowpea daily for days 11-15 and then 150g of cowpea daily for days 16-20

干预措施: cowpea variety #1 (Dietary Supplement)

cowpea variety #2

Experimental

25g of cowpea daily for days 6-10, 50g of cowpea daily for days 11-15 and then 75g of cowpea daily for days 16-20. The pregnant women will receive 50g of cowpea daily for days 6-10, 100g of cowpea daily for days 11-15 and then 150g of cowpea daily for days 16-20

干预措施: cowpea variety #2 (Dietary Supplement)

结局指标

主要结局

Metabolomic profiling of Urine and Plasma

时间窗: 20 days

The study will look at the levels of cowpea metabolite in urine after 20 days of consuming a diet with different cowpeas. Comparing the level of metabolites in urine at the end of study with the start after the participant consumes no cowpea for 5 days after enrollment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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