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临床试验/NCT01935362
NCT01935362已完成1 期

Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health

University of Leeds2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
2
主要终点
blood pressure

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed. Several different measurements can be used to determine blood vessel health; such as blood pressure (BP), and newer techniques which measure blood flow through the arteries after a blood pressure cuff restricts blood flow for a few minutes in one arm.

Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk of CVD. From the previous studies, there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine. A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere from 0-57% of the dose. Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed, and this is not often considered in human studies.

This study is a 4-week double-blinded, randomized, cross-over intervention trial using a commercially-available orange juice supplement and a placebo control. The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks. Furthermore, to determine if there is a relationship between absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or blood vessel health.

The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for 12 weeks. On each study day they will have their weight, height, waist circumference, and blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24 hr on each of the study days, and to consume the supplements provided daily for two sets of 4 weeks (there will be 4 weeks in the middle without any supplements).

An improvement in blood pressure and/or blood flow will provide evidence that blood vessel health has improved through short-term (4 week) use of a citrus flavonoid supplement

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No known cardiovascular disease or diabetes
  • Age between 30-60 years
  • Heavier than average (Body mass index, BMI ≥ 25 kg/m2)
  • Currently non smoker
  • Willing to consume orange juice supplements for 2 months
  • Male and female are equally eligible as not mentioned on advert

排除标准

  • Those who Taken any antibiotics in the 2 months prior to the study
  • Those who consume dietary or herbal supplements
  • previous surgery on gastrointestinal tract
  • Those who currently taking medication
  • Current smokers, or ex-smokers ceasing < 3 months ago
  • pregnant or breast feeding
  • Those with known allergies to the intervention treatment

结局指标

主要结局

blood pressure

时间窗: Baseline and 4 weeks

Change in systolic and diastolic blood pressure

An improvement in blood flow

时间窗: Baseline and 4 weeks

Change in blood flow using Endo-PAT device

次要结局

  • bioavailability of flavanones compounds(Baseline and 4 weeks)
  • blood glucose(Baseline and 4 weeks)

研究者

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

Abdurrahman M Sweidan

Mr

University of Leeds

研究点 (2)

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