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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014