Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Disorder of the Cardiovascular System
• Intervention / Treatment: Dietary supplement: Polyphenols; Dietary supplement: Placebo controlled

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Group receiving capsules with polyphenols.	Dietary supplement: Polyphenols; Capsules with five substances (polyphenols) at a concentration of 3000mg per day
Placebo Comparator: Placebo controlled group; Group receiving capsules with starch.	Dietary supplement: Placebo controlled; Starch capsules

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High sensitive C reactive protein	markers analyzed in plasma	Baseline; 15 days

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Study Director: Paulo Zielinsky, cardiologist, Instituto de Cardiologia do Rio Grande do Sul

Publications and helpful links

General Publications

• Zielinsky P, Piccoli AL Jr, Manica JL, Nicoloso LH, Vian I, Bender L, Pizzato P, Pizzato M, Swarowsky F, Barbisan C, Mello A, Garcia SC. Reversal of fetal ductal constriction after maternal restriction of polyphenol-rich foods: an open clinical trial. J Perinatol. 2012 Aug;32(8):574-9. doi: 10.1038/jp.2011.153. Epub 2011 Nov 3.

Helpful Links

• The effects of dietary polyphenols on reproductive health and early development.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Polyphenols, Prostaglandin E2, hormonal contraceptives
• Other Study ID Numbers: 4547/12; U1111-1173-3333 (Other Identifier: UTN)