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OpenTrials
Completed

NCT Number: NCT04103294

Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

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.

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Key information

Conditions

Age range

9 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Health Sciences, University of Ghana

Accra, Mion and Nanton District, Ghana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

cowpea variety #1

Dietary Supplement

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

cowpea variety #2

Dietary Supplement

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

Primary outcomes

  1. Metabolomic profiling of Urine and Plasma

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • College of Health Sciences, University of Ghana, Legon
  • Michigan State University
  • Project Peanut Butter, Ghana

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2019
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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