Chocolate Consumption in Healthy Pregnant Women Trial

NCT ID: NCT01659060

Last Updated: 2012-08-07

Basic Information

• 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

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.

Conditions

Hypertension Pregnancy-induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

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

Chocolate rich in flavanols; Flavanol-free chocolate

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Dodin, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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

Québec, Quebec, Canada

Countries

Canada

References

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

119.05.03

Identifier Type: -

Identifier Source: org_study_id