Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Inflammatory Disorder of the Cardiovascular System

Intervention / Treatment
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* Dietary Supplement: Polyphenols
* Dietary Supplement: Placebo controlled


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Group receiving capsules with polyphenols. | Dietary Supplement: Polyphenols<br>* Capsules with five substances (polyphenols) at a concentration of 3000mg per day<br>|
| Placebo Comparator: Placebo controlled group<br>Group receiving capsules with starch. | Dietary Supplement: Placebo controlled<br>* Starch capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostaglandin E2 | markers analyzed in plasma | Baseline; 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F2 isoprostane | marker analyzed i urine | Baseline; 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyphenols, Prostaglandin E2, hormonal contraceptives