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临床试验/NCT05750316
NCT05750316已完成不适用

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

University of Reading2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in postprandial blood glucose measured by incremental area under the curve and area under the curve

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change in postprandial blood glucose measured by incremental area under the curve and area under the curve

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte E Mills

Lecturer

University of Reading

研究点 (2)

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