Viewing Study NCT04103294



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Study NCT ID: NCT04103294
Status: COMPLETED
Last Update Posted: 2019-09-25
First Post: 2019-06-12

Brief Title: Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
Sponsor: Washington University School of Medicine
Organization: Washington University School of Medicine

Study Overview

Official Title: Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
Status: COMPLETED
Status Verified Date: 2019-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 30-88A 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None