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

Laval University1 site in 1 country44 target enrollmentJuly 2008

ConditionsHypertension Pregnancy-induced

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hypertension Pregnancy-induced
Sponsor: Laval University
Enrollment: 44
Locations: 1
Primary Endpoint: Changes in endothelial function and blood pressure
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

April 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Laval University

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Changes in endothelial function and blood pressure

Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline)

Secondary Outcomes

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))