Impact of Consumption of Cowpea Leaves on Blood Glucose

Blood Glucose Clinical Trial

Official title:

Impact of Consumption of Cowpea Leaves on Blood Glucose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750316
• Other study ID #: 06/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2023
• Source: University of Reading
• Contact: Charlotte E Mills, PhD
• Phone: 01183787108
• Email: c.e.mills[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Polyphenols, which are abundant in vegetables, may influence how the body utilises carbohydrates. Cowpea, also referred to as black-eyed peas (Vigna unguiculata (L.) Walp.) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Other:
• Cowpea leaves mixed with Jam
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 colour
Jam with green food colouring spread on bread

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose	Blood glucose measured by continous glucose monitor	At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)
Secondary	Change in blood pressure	Systolic and diastolic blood pressure by blood pressure monitor	At baseline (t=0 hours) and every 30 minute until (t=3 hours)
Secondary	Microvascular blood flow	Microvascular blood flow using Laser doppler Imaging with Iontophoresis	At baseline (t=0 hours) and (t=2.5 hours)