Chocolate Consumption in Healthy Pregnant Women Trial

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Hypertension Pregnancy-induced

Intervention / Treatment
-----------------
* Other: Flavanol-rich dark chocolate
* Other: Placebo Chocolate


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dark chocolate<br> | Other: Flavanol-rich dark chocolate<br>* 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.<br>* Other names: Chocolate rich in flavanols;|
| Placebo Comparator: Placebo chocolate<br> | Other: Placebo Chocolate<br>* Placebo intervention<br>* Other names: Flavanol-free chocolate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in endothelial function and blood pressure |  | within the first 12 weeks of chocolate intake (week 12 and baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cacao, Chocolate, Theobromine, Flavonoids, Pregnant women, Hypertension pregnancy-induced, Pre-eclampsia, Epicatechin