Chocolate Consumption in Healthy Pregnant Women Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01659060
First received: July 31, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Hypertension Pregnancy-induced
Other: Flavanol-rich dark chocolate
Other: Placebo Chocolate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Changes in endothelial function and blood pressure [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]
  • Weight change from baseline at 12 weeks [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]
  • Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache) [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dark chocolate 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.
Other Name: Chocolate rich in flavanols
Placebo Comparator: Placebo chocolate Other: Placebo Chocolate
Placebo intervention
Other Name: Flavanol-free chocolate

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659060

Locations
Canada, Quebec
Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels
Québec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Sylvie Dodin, MD Laval University
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01659060     History of Changes
Other Study ID Numbers: 119.05.03
Study First Received: July 31, 2012
Last Updated: August 2, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
Cacao
Chocolate
Theobromine
Flavonoids
Pregnant women
Hypertension pregnancy-induced
Pre-eclampsia
Epicatechin

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 22, 2014