Dietary ExposureNCT04103294
Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
A study testing cowpea variety #1 and cowpea variety #2 in people with Dietary Exposure, run by Washington University School of Medicine at 1 site in Ghana.
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. Read more about this study
- Who is it for?
- Ages 9 months and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- cowpea variety #1 and cowpea variety #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGhana
- Study dates
- 25 Jul 2019to 16 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy children between the ages of 9-21 months and pregnant women > 18 years of age and between 20-25 weeks of gestation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ghana1 site
College of Health Sciences, University of Ghana
Accra, Mion and Nanton District
About this study
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
- Being tested
- cowpea variety #1, cowpea variety #2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cowpea variety #1Dietary supplement
two most popular varieties of cowpea currently consumed in the selected geographic area
cowpea variety #2Dietary supplement
two most popular varieties of cowpea currently consumed in the selected geographic area
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: cowpea variety #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start25 Jul 2019
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- College of Health Sciences, University of Ghana, Legon, Project Peanut Butter, Ghana, Michigan State University
- Responsible party
- Sponsor
- Investigators
- Mark Manary, MD, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103294
- Sponsor's protocol ID
- 201905103
- Status last verified
- Sep 2019
- First submitted
- 12 Jun 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tipton M, Baxter BA, Pfluger BA, Sayre-Chavez B, Munoz-Amatriain M, Broeckling CD, Shani I, Steiner-Asiedu M, Manary M, Ryan EP. Urine and Dried Blood Spots From Children and Pregnant Women Reveal Phytochemicals, Amino Acids, and Carnitine Metabolites as Cowpea Consumption Biomarkers. Mol Nutr Food Res. 2024 Feb;68(4):e2300222. doi: 10.1002/mnfr.202300222. Epub 2024 Jan 17.
PubMed 38233141
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
- ClinicalTrials.gov ID
- NCT04103294
- Acronym / sponsor ID
- 201905103
- Conditions
- Dietary Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- College of Health Sciences, University of Ghana, Legon, Project Peanut Butter, Ghana, Michigan State University
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cowpea variety #1 | Experimental | Dietary Supplement: cowpea variety #125g 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 |
| cowpea variety #2 | Experimental | Dietary Supplement: cowpea variety #225g 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 |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy children between the ages of 9-21 months and pregnant women > 18 years of age and between 20-25 weeks of gestation.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cowpea variety #1two most popular varieties of cowpea currently consumed in the selected geographic area | Dietary supplement | cowpea variety #1 |
| cowpea variety #2two most popular varieties of cowpea currently consumed in the selected geographic area | Dietary supplement | cowpea variety #2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 38233141Tipton M, Baxter BA, Pfluger BA, Sayre-Chavez B, Munoz-Amatriain M, Broeckling CD, Shani I, Steiner-Asiedu M, Manary M, Ryan EP. Urine and Dried Blood Spots From Children and Pregnant Women Reveal Phytochemicals, Amino Acids, and Carnitine Metabolites as Cowpea Consumption Biomarkers. Mol Nutr Food Res. 2024 Feb;68(4):e2300222. doi: 10.1002/mnfr.202300222. Epub 2024 Jan 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Manary, MD principal investigator
Washington University School of Medicine in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cowpea variety #1 and cowpea variety #2 in people with Dietary Exposure, run by Washington University School of Medicine at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic profiling of Urine and Plasma (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.