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.

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Dietary supplement: cowpea variety #1; Dietary supplement: cowpea variety #2

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Mion And Nanton District
    • Accra, Mion And Nanton District, Ghana
      • College of Health Sciences, University of Ghana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cowpea variety #1; 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	Dietary supplement: cowpea variety #1; two most popular varieties of cowpea currently consumed in the selected geographic area
Experimental: cowpea variety #2; 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	Dietary supplement: cowpea variety #2; two most popular varieties of cowpea currently consumed in the selected geographic area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Michigan State University; Project Peanut Butter, Ghana; College of Health Sciences, University of Ghana, Legon
• Investigators: Principal Investigator: Mark Manary, MD, Washington University School of Medicine in St. Louis

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): September 16, 2019
• Study Completion (Actual): September 16, 2019

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201905103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No