Clinical trial NCT02567617: Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial
Official title: Polyphenol Supplementation Inhibits Physiological Increase of Prostaglandin E2 During Reproductive Period - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Disorder of the Cardiovascular System
Keywords: Polyphenols, Prostaglandin E2, hormonal contraceptives
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 26
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostaglandin E2
timeFrame: Baseline; 15 days
Secondary outcomes:
measure: F2 isoprostane
timeFrame: Baseline; 15 days
Other outcomes:
measure: High sensitive C reactive protein
timeFrame: Baseline; 15 days
Locations:
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Paulo Zielinsky, cardiologist
role: STUDY_DIRECTOR
References:
citation: 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.