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Clinical Trials/NCT05750316
NCT05750316CompletedNot Applicable

Effect of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Healthy Black Adults: A Randomised Controlled Pilot Study

University of Reading1 site in 1 country12 target enrollmentStarted: March 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Change in postprandial blood glucose measured by incremental area under the curve and area under the curve

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Cowpea leaves mixed with Jam (Other)

Jam with green food colour

Active Comparator

Apricot jam mixed with green colouring and spread on bread

Intervention: Jam mixed with green food colour (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charlotte E Mills

Lecturer

University of Reading

Study Sites (1)

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