Chocolate Consumption in Healthy Pregnant Women Trial

Laval University

Status and phase: Completed; Phase 2

Conditions: Hypertension Pregnancy-induced

Treatments: Other: Placebo Chocolate; Other: Flavanol-rich dark chocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT01659060

119.05.03

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Dark chocolate

Experimental group

Treatment:

Other: Flavanol-rich dark chocolate

Placebo chocolate

Placebo Comparator group

Treatment:

Other: Placebo Chocolate