Consumption of Chocolate in Pregnant Women.

Preeclampsia Clinical Trial

— CHOCENTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431443
• Other study ID #: IC096501
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2011
• Last updated: April 8, 2015
• Start date: May 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• Flavanol-rich chocolate
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
Placebo intervention

Locations

Country	Name	City	State
Canada	Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in endothelial function		within the first 12 weeks of chocolate intake	No
Secondary	Doppler of uterine arteries		within the first 12 weeks of chocolate intake	No
Secondary	Blood pressure		within the first 12 weeks of chocolate intake	No
Secondary	Plasma biomarker of endothelium function		within the first 12 weeks of chocolate intake	No
Secondary	Plasma biomarker of chocolate intake	ng\ml plasma	within the first 12 weeks of chocolate intake	No