Polyphenols Supplementation on Prostaglandin E2 in Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

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.

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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.

Conditions

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Inflammatory Disorder of the Cardiovascular System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Group receiving capsules with polyphenols.

Group Type ACTIVE_COMPARATOR

Polyphenols

Intervention Type DIETARY_SUPPLEMENT

Capsules with five substances (polyphenols) at a concentration of 3000mg per day

Placebo controlled group

Group receiving capsules with starch.

Group Type PLACEBO_COMPARATOR

Placebo controlled

Intervention Type DIETARY_SUPPLEMENT

Starch capsules

Interventions

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Polyphenols

Capsules with five substances (polyphenols) at a concentration of 3000mg per day

Intervention Type DIETARY_SUPPLEMENT

Placebo controlled

Starch capsules

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes