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Chocolate Consumption in Healthy Pregnant Women Trial

Information source: Laval University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension Pregnancy-induced

Intervention: Flavanol-rich dark chocolate (Other); Placebo Chocolate (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Laval University

Official(s) and/or principal investigator(s):
Sylvie Dodin, MD, Principal Investigator, Affiliation: Laval University

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.

Clinical Details

Official title: Assessment of Blood Pressure and Endothelial Function Pregnancy After Acute and Daily Consumption Flavanol-rich Chocolate Among Healthy Pregnant Women: a Pilot Randomized Controlled Trial

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

Primary outcome: Changes in endothelial function and blood pressure

Secondary outcome:

Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks

Weight change from baseline at 12 weeks

Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels, Qu├ębec, Quebec G1V 0A6, Canada
Additional Information

Starting date: July 2008
Last updated: August 2, 2012

Page last updated: August 23, 2015

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