Polyphenols Supplementation on Prostaglandin E2 in Women... | NCT02567617

Studies
Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial

NCT02567617

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

26Actual

Phase

Phase 2

Conditions

Inflammatory Disorder of the Cardiovascular System

Interventions

Polyphenols
Placebo controlled

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1173-3333	Other Identifier	UTN

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Oct 1, 2015

First Posted Date

Oct 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2015

Last Update Posted Date

Oct 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ana Maria Arregui Zilio, nutricionista, Instituto de Cardiologia do Rio Grande do SulPrincipal Investigator

Lead Sponsor

Instituto de Cardiologia do Rio Grande do SulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Active Comparator	Group receiving capsules with polyphenols.	Dietary Supplement: Polyphenols
Placebo controlled group	Placebo Comparator	Group receiving capsules with starch.	Dietary Supplement: Placebo controlled

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polyphenols	Dietary Supplement	Capsules with five substances (polyphenols) at a concentration of 3000mg per day	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prostaglandin E2	markers analyzed in plasma	Baseline; 15 days

Secondary Outcomes

Measure	Description	Time Frame
F2 isoprostane	marker analyzed i urine	Baseline; 15 days

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paulo Zielinsky, cardiologist	Instituto de Cardiologia do Rio Grande do Sul	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22052330	Background	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.

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic