Chocolate Consumption in Healthy Pregnant Women Trial

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659060

Enrollment

Registered

2012-08-07

Start date

2008-07-31

Completion date

2009-04-30

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Pregnancy-induced

Keywords

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

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.

Interventions

OTHERFlavanol-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.

OTHERPlacebo Chocolate

Placebo intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame
Changes in endothelial function and blood pressure	within the first 12 weeks of chocolate intake (week 12 and baseline)

Secondary

Measure	Time frame
Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks	within the first 12 weeks of chocolate intake (week 12 and baseline)
Weight change from baseline at 12 weeks	within the first 12 weeks of chocolate intake (week 12 and baseline)
Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)	within the first 12 weeks of chocolate intake (week 12 and baseline)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026