Polyphenol Supplementation Inhibits Physiological Increase of Prostaglandin E2 During Reproductive Period - A Randomized Clinical Trial
| Registry | NCT02567617 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 26 (Actual) |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul (Other) |
| Conditions | Inflammatory Disorder of the Cardiovascular System |
| Interventions | Polyphenols, Placebo controlled (Dietary supplement) |
| Dates | start 2014-05-01, primary completion 2014-08-01, completion 2015-03-01, first posted 2015-10-05, last updated 2015-10-05 |
Related Papers Related Patents Related Grants Related Experts
All trials for Inflammatory Disorder of the Cardiovascular System All trials of Polyphenols All trials of Placebo controlled
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Polyphenols | Group receiving capsules with polyphenols. |
| Placebo controlled group | Placebo comparator | Dietary Supplement: Placebo controlled | Group receiving capsules with starch. |
Sex: Female, ages: 25 Years to 35 Years, accepts healthy volunteers
Inclusion Criteria: * Women aged 25 to 35 * Use of hormonal contraceptives * Agreed to participate and signed the Informed Consent Exclusion Criteria: * 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