Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

Phase 2

Completed

• Conditions: Inflammatory Disorder of the Cardiovascular System
• Interventions: Dietary Supplement: Polyphenols; Dietary Supplement: Placebo controlled

• Registration Number: NCT02567617
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Study First Submitted: 2015-09-30
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-01
• Last Update Submitted: 2015-10-01
• Study First Posted: 2015-10-05
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Polyphenols	Group receiving capsules with polyphenols.
Placebo controlled group	Placebo controlled	Group receiving capsules with starch.

Primary Outcome Measures

Name	Time	Method
Prostaglandin E2	Baseline; 15 days	markers analyzed in plasma

Secondary Outcome Measures

Name	Time	Method
F2 isoprostane	Baseline; 15 days	marker analyzed i urine