Impact of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Black Adults, a Pilot Study

NCT ID: NCT05750316

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-07-13

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Freeze dried cowpea leaves mixed in jam

6g of freeze-dried cowpea leaves (equivalent to one portion of vegetables) mixed with apricot jam and spread on bread.

Group Type: EXPERIMENTAL

Cowpea leaves mixed with Jam

Intervention Type: OTHER

6g of freeze-dried cowpea leaves, equivalent to 80g(a portion) of vegetables mixed with Jam and spread on bread

Jam with green food colour

Apricot jam mixed with green colouring and spread on bread

Group Type: ACTIVE_COMPARATOR

Jam mixed with green food colour

Intervention Type: OTHER

Jam with green food colouring spread on bread

Interventions

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

Intervention Type: OTHER

Jam mixed with green food colour

Jam with green food colouring spread on bread

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Charlotte E Mills

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Reading

Reading, , United Kingdom

Countries

United Kingdom

Other Identifiers

06/2023

Identifier Type: -

Identifier Source: org_study_id