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Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

NCT04103294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-09-25

No results posted yet for this study

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 30-88%.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.

Conditions

  • Dietary Exposure

Interventions

DIETARY_SUPPLEMENT

cowpea variety #1

two most popular varieties of cowpea currently consumed in the selected geographic area

DIETARY_SUPPLEMENT

cowpea variety #2

two most popular varieties of cowpea currently consumed in the selected geographic area

Sponsors & Collaborators

  • College of Health Sciences, University of Ghana, Legon

    collaborator UNKNOWN

  • Project Peanut Butter, Ghana

    collaborator UNKNOWN

  • Michigan State University

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark Manary, MD · Washington University School of Medicine in St. Louis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2019-09-16
Completion
2019-09-16

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103294 on ClinicalTrials.gov