Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Completed; Phase 2

Conditions: Inflammatory Disorder of the Cardiovascular System

Treatments: Dietary Supplement: Placebo controlled; Dietary Supplement: Polyphenols

Study type: Interventional

Funder types: Other

Identifiers

NCT02567617

U1111-1173-3333 (Other Identifier)

4547/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Group receiving capsules with polyphenols.

Treatment:

Dietary Supplement: Polyphenols

Placebo controlled group

Placebo Comparator group

Description:

Group receiving capsules with starch.

Treatment:

Dietary Supplement: Placebo controlled