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OpenTrials
Completed

NCT Number: NCT05750316

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

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Key information

Conditions

Black Ethnicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, RG6 6AH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Jam mixed with green food colour

Other

Jam with green food colouring spread on bread

Primary outcomes

  1. 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

  1. Change in blood pressure

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

    Systolic and diastolic blood pressure by blood pressure monitor

  2. Microvascular blood flow

    Time frame: At baseline (t=0 hours) and (t=2.5 hours)

    Microvascular blood flow using Laser doppler Imaging with Iontophoresis

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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