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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 31, 2012

Last Updated Date

August 2, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01659060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chocolate Consumption in Healthy Pregnant Women Trial

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension Pregnancy-induced

Intervention ^ICMJE

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
Other: Placebo Chocolate
Placebo intervention

Other Name: Flavanol-free chocolate

Study Arm (s)

Experimental: Dark chocolate
Intervention: Other: Flavanol-rich dark chocolate
Placebo Comparator: Placebo chocolate
Intervention: Other: Placebo Chocolate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01659060

Other Study ID Numbers ^ICMJE

119.05.03

Has Data Monitoring Committee

Yes

Responsible Party

Laval University

Study Sponsor ^ICMJE

Laval University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sylvie Dodin, MD

Laval University

Information Provided By

Laval University

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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