Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana

NCT04103294 | Completed

• 1 other identifier: 201905103
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 30-88%.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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cowpea variety #1

EXPERIMENTAL

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

cowpea variety #2

EXPERIMENTAL

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

Interventions

cowpea variety #1 DIETARY_SUPPLEMENT

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

cowpea variety #1

cowpea variety #2 DIETARY_SUPPLEMENT

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

cowpea variety #2

Eligibility Criteria

• Age: 9 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• College of Health Sciences, University of Ghana, Legon: collaborator
• Project Peanut Butter, Ghana: collaborator
• Michigan State University: collaborator

Study Sites (1)

College of Health Sciences, University of Ghana

Accra, Mion and Nanton District, Ghana

Location

Study Officials

• Mark Manary, MD

  Washington University School of Medicine in St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: September 25, 2019
• Study Start: July 25, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

GH (1)