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临床试验/NCT01272167
NCT01272167已完成不适用

Effects of a Long-term and Regular Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism : a Cross-over Designed Study to Determine the Specific Role of Naringin

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010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
发起方
入组人数
52
试验地点
2

研究概览

简要总结

Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

详细描述

Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

Some scientific data obtained from animal studies or in vitro experiments suggested that flavanones could exert positive effects on several biomarkers of the cardiovascular or osteoporosis risks. However, until now, the clinical proof of the efficacy of these compounds is far to be obtained and more clinical trials are needed.

The main goals of this project are (1) to characterize the effect of a long-term grapefruit juice consumption on both vascular and bone protections and (2) to assess the specific role of naringin, in these potential protective effects.

To reach these goals, a randomized, cross-over clinical trial will be performed on 52 healthy post-menopausal women (50 to 65 years old, 3 to 10 years since menopause, waist > 88 cm). Such a population shares an increased risk of CVD and osteoporosis.

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 (Participant, Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Caucasian healthy post-menopausal women
  • 19≤ BMI ≤29 and waist measurement > 88 cm

排除标准

  • Metabolic diseases
  • Hypertension
  • Taking CYP3A4-metabolized drugs
  • Taking blood lipids lowering drugs or antihypertensive drugs
  • Hypercholesterolemia with HDL < 1.30 mmol/L (i.e. < 0.5 g/L)
  • Osteoporosis (defined by T-score of -2.5 SD at hip and/or lumbar spine)
  • Taking hormone replacement therapy (HRT)
  • Taking dietary supplements

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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