A Phase 2 interventional study of Polyphenols and Placebo controlled in Inflammatory Disorder of the Cardiovascular System, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed. Open to female participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-05.
Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Phase 2, Interventional, and Prevention
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.
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.
Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Group receiving capsules with polyphenols.
Dietary Supplement: Polyphenols
Group receiving capsules with starch.
Dietary Supplement: Placebo controlled
Capsules with five substances (polyphenols) at a concentration of 3000mg per day
Starch capsules
Prostaglandin E2
markers analyzed in plasma
Time frame: Baseline; 15 days
F2 isoprostane
marker analyzed i urine
Time frame: Baseline; 15 days
High sensitive C reactive protein
markers analyzed in plasma
Time frame: Baseline; 15 days
No study locations are listed for this record.
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Instituto de Cardiologia do Rio Grande do Sul