Chocolate Consumption in Healthy Pregnant Women Trial

Hypertension Pregnancy-induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659060
• Other study ID #: 119.05.03
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2012
• Last updated: August 2, 2012
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hypertension Pregnancy-induced
• Pre-Eclampsia

Intervention

Other:
• Flavanol-rich dark chocolate
The primary objective of this pilot RCT is to test the feasibility of design methods and procedures for later use on a larger scale. The secondary objective is to examine the acute and chronic effect of dark chocolate on endothelial function and blood pressure, among healthy pregnant women.
• 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 and blood pressure		within the first 12 weeks of chocolate intake (week 12 and baseline)	No
Secondary	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)	No
Secondary	Weight change from baseline at 12 weeks		within the first 12 weeks of chocolate intake (week 12 and baseline)	No
Secondary	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)	No