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

NCT05750316 | Completed

• 1 other identifier: 06/2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Black ethnicity; Blood Glucose; Leaves; Cowpea; Vegetable

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)

Secondary Outcomes (2)

• Change in blood pressure

  At baseline (t=0 hours) and every 30 minute until (t=3 hours)

• Microvascular blood flow

  At baseline (t=0 hours) and (t=2.5 hours)

Study Arms (2)

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.

Other: Cowpea leaves mixed with Jam

Jam with green food colour

ACTIVE COMPARATOR

Apricot jam mixed with green colouring and spread on bread

Other: Jam mixed with green food colour

Interventions

Cowpea leaves mixed with Jam OTHER

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

Freeze dried cowpea leaves mixed in jam

Jam mixed with green food colour OTHER

Jam with green food colouring spread on bread

Jam with green food colour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, RG6 6AH, United Kingdom

Location

MeSH Terms

Interventions

Junctional Adhesion Molecule A

Intervention Hierarchy (Ancestors)

Junctional Adhesion Molecules; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Tight Junction Proteins; Antigens, Surface; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: March 1, 2023
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)