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临床试验/NCT02567617
NCT02567617已完成2 期

Polyphenol Supplementation Inhibits Physiological Increase of Prostaglandin E2 During Reproductive Period - A Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul0 个研究点目标入组 26 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
26
主要终点
Prostaglandin E2

研究概览

简要总结

The aim of this study was to evaluate the effect of polyphenol supplementation on plasma levels of prostaglandin E2 in women during the reproductive period.

详细描述

The effect of anti-inflammatory substances on the constriction of the fetal ductus arteriosus is well documented, but the anti-inflammatory property of polyphenols and their effect on the metabolism of prostaglandins are not established. Evidence indicates that foods rich in polyphenols consumed from the third trimester of pregnancy may interfere with anatomical and functional activity of the fetal heart, presumably by the action similar to anti-inflammatory drugs nonsteroidal, causing inhibitory effect on prostaglandin synthesis. Objective: The objective of this study was to evaluate the effect of polyphenol supplementation on plasma levels of prostaglandin E2 in women of childbearing age use of hormonal contraceptives. As secondary endpoints were also evaluated other markers of inflammation and oxidative stress. The selected women were randomized to receive capsules polyphenol at a concentration of 3000 mg / day or placebo capsules to be consumed daily for fifteen days. Was applied dietary recall to assess intake of polyphenols, measured height and weight and carried blood samples for prostaglandin analysis E2 (PGE2), high sensitive C-reactive protein, and urine for analysis of total polyphenols and F2 isoprostane (8 iso-PGF2a). Statistical analysis: The results will be expressed through absolute and relative frequencies and mean ± standard deviation (SD) or median and interquartile range. For analysis, Pearson correlation is used. To compare the means will be used Student's t test. The level of significance is 5%. Considering a 90% power, with absolute error margin of 5% in the present study, 13 patients were needed in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 25 to 35
  • Use of hormonal contraceptives
  • Agreed to participate and signed the Informed Consent

排除标准

  • Pregnant women
  • Use of anti-inflammatory drugs
  • Using supplementation of omega 3
  • BMI higher than 30 kg / m²
  • Previous diagnosis of diabetes mellitus, hypertension, dyslipidemia, malignancy or infection

结局指标

主要结局

Prostaglandin E2

时间窗: Baseline; 15 days

markers analyzed in plasma

次要结局

  • F2 isoprostane(Baseline; 15 days)

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Maria Arregui Zilio

nutricionista

Instituto de Cardiologia do Rio Grande do Sul

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