Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

Dietary Exposure Clinical Trial

Official title:

Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103294
• Other study ID #: 201905103
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: September 16, 2019

Study information

• Verified date: September 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

Dietary Supplement:
• cowpea variety #1
two most popular varieties of cowpea currently consumed in the selected geographic area
• cowpea variety #2
two most popular varieties of cowpea currently consumed in the selected geographic area

Locations

Country	Name	City	State
Ghana	College of Health Sciences, University of Ghana	Accra	Mion And Nanton District

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	College of Health Sciences, University of Ghana, Legon, Michigan State University, Project Peanut Butter, Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic profiling of Urine and Plasma	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.	20 days