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CompletedNCT02567617Updated Oct 5, 2015

Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

A Phase 2 interventional study of Polyphenols and Placebo controlled in Inflammatory Disorder of the Cardiovascular System, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed. Open to female participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-05.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Inflammatory Disorder of the Cardiovascular System

Keywords

  • Polyphenols, Prostaglandin E2, hormonal contraceptives
03

In context

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women aged 25 to 35
  • Use of hormonal contraceptives
  • Agreed to participate and signed the Informed Consent

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Intervention group

    Group receiving capsules with polyphenols.

    Dietary Supplement: Polyphenols

  • Placebo comparator
    Placebo controlled group

    Group receiving capsules with starch.

    Dietary Supplement: Placebo controlled

Interventions

  • Dietary supplementPolyphenols

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

  • Dietary supplementPlacebo controlled

    Starch capsules

06

What researchers measure

Primary outcomes

  1. Prostaglandin E2

    markers analyzed in plasma

    Time frame: Baseline; 15 days

Secondary outcomes

  1. F2 isoprostane

    marker analyzed i urine

    Time frame: Baseline; 15 days

Other outcomes

  1. High sensitive C reactive protein

    markers analyzed in plasma

    Time frame: Baseline; 15 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 22052330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02567617
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Ana Maria Arregui Zilio (nutricionista, Instituto de Cardiologia do Rio Grande do Sul) — Principal investigator
First posted
Oct 5, 2015
Start date
May 2014
Primary completion
Aug 2014
Completion
Mar 2015
Last update
Oct 5, 2015

Study contacts

Paulo Zielinsky, cardiologist
study director · Instituto de Cardiologia do Rio Grande do Sul

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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