NCT02567617

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

September 30, 2015

Last Update Submit

October 1, 2015

Conditions

Inflammatory Disorder of the Cardiovascular System

Keywords

Polyphenols, Prostaglandin E2, hormonal contraceptives

Outcome Measures

Primary Outcomes (1)

  • Prostaglandin E2

    markers analyzed in plasma

    Baseline; 15 days

Secondary Outcomes (1)

  • F2 isoprostane

    Baseline; 15 days

Other Outcomes (1)

  • High sensitive C reactive protein

    Baseline; 15 days

Study Arms (2)

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

PolyphenolsDIETARY_SUPPLEMENT

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

Intervention group
Placebo controlledDIETARY_SUPPLEMENT

Starch capsules

Placebo controlled group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22052330BACKGROUND

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Paulo Zielinsky, cardiologist

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nutricionista

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 5, 2015

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

October 5, 2015

Record last verified: 2015-10