Black EthnicityNCT05750316
Impact of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Black Adults, a Pilot Study
A study testing Cowpea leaves mixed with Jam and Jam mixed with green food colour in people with Black Ethnicity, run by University of Reading at 1 site in United Kingdom.
Trial summary
Intake of foods high in carbohydrates causes a spike in glucose in the blood. Repeated high blood glucose spikes are associated with an increased risk of diabetes. People of black ethnicity have higher risk of diabetes. Vegetables may help in the regulation of blood glucose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Black Ethnicity
- What is being tested?
- Cowpea leaves mixed with Jam and Jam mixed with green food colour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 13 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years
- Participants from Black, Black British, Caribbean or African ethnic backgrounds,which includes: Caribbean, African, Any other Black, Black British, or Caribbean background
- Should be able to give informed consent
- Should be willing to provide GP's contact details
Who cannot join
- Pregnant or lactating mothers
- Special dietary requirements such as vegetarians and vegans
- Participants who are on a specialised diet such as a weight reduction diet
- Having any chronic illness or taking medication for chronic illness
- Participants whose blood results indicate illness
- Participants on mediation for hypertension or hyperlipidaemia
- Sportsmen or women or vigorous exercise for more than 5 times per week
- Alcohol (more than 14 units per week) or drug abusers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Healthy Black Adults: A Randomised Controlled Pilot Study
Intake of foods high in carbohydrates causes a spike in glucose in the blood. Repeated high blood glucose spikes are associated with an increased risk of diabetes. People of black ethnicity have higher risk of diabetes. Vegetables may help in the regulation of blood glucose. Cowpea, also referred to as black-eyed peas (Vigna unguiculata) leaves, contain polyphenols and fibre that can help regulate blood glucose.
The study will be an acute, single-blind, randomised control trial with a cross-over design involving healthy black participants aged ≥18 years. This clinical trial aims to investigate if consuming cowpea leaves can reduce blood glucose spikes after consuming a meal high in carbohydrates. Participants will be randomised to consume either bread with jam containing freeze-dried cowpea leaves (active intervention) or jam without any freeze-dried powder (control group). Blood glucose will be monitored before the intervention and every 15 minutes after the intervention using a continuous glucose monitor.
- Conditions
- Black Ethnicity
- Being tested
- Cowpea leaves mixed with Jam, Jam mixed with green food colour
- Keywords
- Black ethnicity, Blood Glucose, Leaves, Cowpea, Vegetable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cowpea leaves mixed with JamOther
6g of freeze-dried cowpea leaves, equivalent to 80g(a portion) of vegetables mixed with Jam and spread on bread
Jam mixed with green food colourOther
Jam with green food colouring spread on bread
| Study group | Role | What they receive |
|---|---|---|
| Freeze dried cowpea leaves mixed in jam | Experimental | 6g of freeze-dried cowpea leaves (equivalent to one portion of vegetables) mixed with apricot jam and spread on bread. Receives: Other: Cowpea leaves mixed with Jam |
| Jam with green food colour | Active comparator | Apricot jam mixed with green colouring and spread on bread Receives: Other: Jam mixed with green food colour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose measured by incremental area under the curve and area under the curve
Postprandial blood glucose measured by a continuous glucose monitor. The incremental area under curve and area under the curve will be used as a measure of the postprandial blood glucose
Measured: At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)
Secondary outcomes (2)
Change in blood pressure
Systolic and diastolic blood pressure by blood pressure monitor
Measured: At baseline (t=0 hours) and every 30 minute until (t=3 hours)
Microvascular blood flow
Microvascular blood flow using Laser doppler Imaging with Iontophoresis
Measured: At baseline (t=0 hours) and (t=2.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2023
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black EthnicityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte E Mills, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750316
- Sponsor's protocol ID
- 06/2023
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Healthy Black Adults: A Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05750316
- Acronym / sponsor ID
- 06/2023
- Conditions
- Black Ethnicity
- Keywords
- Black ethnicity, Blood Glucose, Leaves, Cowpea, Vegetable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 1 Mar 2023 (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.
Intake of foods high in carbohydrates causes a spike in glucose in the blood. Repeated high blood glucose spikes are associated with an increased risk of diabetes. People of black ethnicity have higher risk of diabetes. Vegetables may help in the regulation of blood glucose. Cowpea, also referred to as black-eyed peas (Vigna unguiculata) leaves, contain polyphenols and fibre that can help regulate blood glucose.
The study will be an acute, single-blind, randomised control trial with a cross-over design involving healthy black participants aged ≥18 years. This clinical trial aims to investigate if consuming cowpea leaves can reduce blood glucose spikes after consuming a meal high in carbohydrates. Participants will be randomised to consume either bread with jam containing freeze-dried cowpea leaves (active intervention) or jam without any freeze-dried powder (control group). Blood glucose will be monitored before the intervention and every 15 minutes after the intervention using a continuous glucose monitor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze dried cowpea leaves mixed in jam | Experimental | Other: Cowpea leaves mixed with Jam6g of freeze-dried cowpea leaves (equivalent to one portion of vegetables) mixed with apricot jam and spread on bread. |
| Jam with green food colour | Active comparator | Other: Jam mixed with green food colourApricot jam mixed with green colouring and spread on bread |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥ 18 years
- Participants from Black, Black British, Caribbean or African ethnic backgrounds,which includes: Caribbean, African, Any other Black, Black British, or Caribbean background
- Should be able to give informed consent
- Should be willing to provide GP's contact details
Key exclusion criteria (8 listed)
- Pregnant or lactating mothers
- Special dietary requirements such as vegetarians and vegans
- Participants who are on a specialised diet such as a weight reduction diet
- Having any chronic illness or taking medication for chronic illness
- Participants whose blood results indicate illness
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 leaves mixed with Jam6g of freeze-dried cowpea leaves, equivalent to 80g(a portion) of vegetables mixed with Jam and spread on bread | Other | Freeze dried cowpea leaves mixed in jam |
| Jam mixed with green food colourJam with green food colouring spread on bread | Other | Jam with green food colour |
Primary outcome
Change in postprandial blood glucose measured by incremental area under the curve and area under the curve
Time frame: At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)
Postprandial blood glucose measured by a continuous glucose monitor. The incremental area under curve and area under the curve will be used as a measure of the postprandial blood glucose
2 secondary outcomes
Change in blood pressure
Time frame: At baseline (t=0 hours) and every 30 minute until (t=3 hours)
Microvascular blood flow
Time frame: At baseline (t=0 hours) and (t=2.5 hours)
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 18 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 leaves mixed with Jam and Jam mixed with green food colour in people with Black Ethnicity, run by University of Reading at 1 site in United Kingdom.
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 4 inclusion and 8 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 18 Jul 2024. 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 United Kingdom. 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?
Change in postprandial blood glucose measured by incremental area under the curve and area under the curve (time frame: At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.