Chocolate Consumption in Healthy Pregnant Women Trial

Phase 2

Completed

• Conditions: Hypertension Pregnancy-induced
• Interventions: Other: Flavanol-rich dark chocolate; Other: Placebo Chocolate

• Registration Number: NCT01659060
• Lead Sponsor: Laval University

Brief Summary

The purpose of this study is to to test the feasibility of design methods and procedures for later use on a larger scale and to examine the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2012-07-31
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-07
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• non-smoking normotensive women aged from 18 to 35 years, between the 7 and 12 weeks of gestation (documented by ultrasound) and having a live fetus confirmed by fetal heart auscultation

Exclusion Criteria

• Patients with family history of premature cardiovascular disease
• Chronic hypertension
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dark chocolate	Flavanol-rich dark chocolate	-
Placebo chocolate	Placebo Chocolate	-

Primary Outcome Measures

Name	Time	Method
Changes in endothelial function and blood pressure	within the first 12 weeks of chocolate intake (week 12 and baseline)

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks	within the first 12 weeks of chocolate intake (week 12 and baseline)
Weight change from baseline at 12 weeks	within the first 12 weeks of chocolate intake (week 12 and baseline)
Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)	within the first 12 weeks of chocolate intake (week 12 and baseline)

Trial Locations

Locations (1)

Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels; 🇨🇦 Québec, Quebec, Canada