Chocolate Consumption in Healthy Pregnant Women Trial

NCT ID: NCT01659060

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Hypertension Pregnancy-induced

Keywords

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Cacao Chocolate Theobromine Flavonoids Pregnant women Hypertension pregnancy-induced Pre-eclampsia Epicatechin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dark chocolate

Group Type EXPERIMENTAL

Flavanol-rich dark chocolate

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Placebo Chocolate

Intervention Type OTHER

Placebo intervention

Interventions

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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.

Intervention Type OTHER

Placebo Chocolate

Placebo intervention

Intervention Type OTHER

Other Intervention Names

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Chocolate rich in flavanols Flavanol-free chocolate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie Dodin, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Mogollon JA, Bujold E, Lemieux S, Bourdages M, Blanchet C, Bazinet L, Couillard C, Noel M, Dodin S. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial. Nutr J. 2013 Apr 8;12:41. doi: 10.1186/1475-2891-12-41.

Reference Type DERIVED
PMID: 23565841 (View on PubMed)

Other Identifiers

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119.05.03

Identifier Type: -

Identifier Source: org_study_id