Chocolate Consumption in Healthy Pregnant Women Trial

Sponsor

Laval University (Other)

Overall Status

Completed

CT.gov ID

NCT01659060

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Pregnancy-induced	Other: Flavanol-rich dark chocolate Other: Placebo Chocolate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dark chocolate	Other: 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. Other Names: Chocolate rich in flavanols
Placebo Comparator: Placebo chocolate	Other: Placebo Chocolate Placebo intervention Other Names: Flavanol-free chocolate

Arm

Intervention/Treatment

Experimental: Dark chocolate

Other: 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.

Other Names:

Chocolate rich in flavanols

Placebo Comparator: Placebo chocolate

Other: Placebo Chocolate

Placebo intervention

Other Names:

Flavanol-free chocolate

Outcome Measures

Primary Outcome Measures

Changes in endothelial function and blood pressure [within the first 12 weeks of chocolate intake (week 12 and baseline)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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.