NCT01431443

Brief Summary

The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

May 2, 2011

Last Update Submit

April 8, 2015

Conditions

Preeclampsia

Keywords

Randomized double blind trialCocoa flavonoidsEndothelial functionBlood pressurePregnant womenPreeclampsiaUterine artery flowPulsatility index

Outcome Measures

Primary Outcomes (1)

  • Changes in endothelial function

    within the first 12 weeks of chocolate intake

Secondary Outcomes (4)

  • Doppler of uterine arteries

    within the first 12 weeks of chocolate intake

  • Blood pressure

    within the first 12 weeks of chocolate intake

  • Plasma biomarker of endothelium function

    within the first 12 weeks of chocolate intake

  • Plasma biomarker of chocolate intake

    within the first 12 weeks of chocolate intake

Study Arms (2)

Dark chocolate

EXPERIMENTAL
Other: Flavanol-rich chocolate

Placebo chocolate

PLACEBO COMPARATOR

Placebo intervention

Other: Placebo Chocolate

Interventions

Flavanol-rich chocolateOTHER

The aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia.

Dark chocolate
Placebo ChocolateOTHER

Placebo intervention

Also known as: Flavanol and theobromine-free chocolate
Placebo chocolate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women between the ages of 18 and 40 years.
  • Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.

You may not qualify if:

  • Hypertension requiring medication.
  • Currently or previously use of medications interfering with glucose or lipids metabolism.
  • Use of supplements or natural health products that interfere with blood pressure.
  • Consumption of 1 or more alcohol drink per day.
  • Allergy or intolerance to nuts or chocolate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sylvie Dodin, MD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

September 9, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

CA(1)