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Completed

NCT Number: NCT01431443

Consumption of Chocolate in Pregnant Women.

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Québec, Quebec, G1V 0A6, Canada

About this study

Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.

The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Flavanol-rich chocolate

Other

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.

Placebo Chocolate

Other

Placebo intervention

Other names: Flavanol and theobromine-free chocolate

Primary outcomes

  1. Changes in endothelial function

    Time frame: within the first 12 weeks of chocolate intake

Secondary outcomes

  1. Doppler of uterine arteries

    Time frame: within the first 12 weeks of chocolate intake

  2. Blood pressure

    Time frame: within the first 12 weeks of chocolate intake

  3. Plasma biomarker of endothelium function

    Time frame: within the first 12 weeks of chocolate intake

  4. Plasma biomarker of chocolate intake

    Time frame: within the first 12 weeks of chocolate intake

    ng\\ml plasma

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.

Acronym: CHOCENTA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2011
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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