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Completed

NCT Number: NCT02567617

Polyphenols Supplementation on Prostaglandin E2 in Women - 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.

Completed

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyphenols

Dietary Supplement

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

Placebo controlled

Dietary Supplement

Starch capsules

Primary outcomes

  1. Prostaglandin E2

    Time frame: Baseline; 15 days

    markers analyzed in plasma

Secondary outcomes

  1. F2 isoprostane

    Time frame: Baseline; 15 days

    marker analyzed i urine

Other outcomes

  1. High sensitive C reactive protein

    Time frame: Baseline; 15 days

    markers analyzed in plasma

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Oct 5, 2015
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.