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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
44
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 intervention
Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels
Québec, Quebec, Canada
Changes in endothelial function and blood pressure
Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)
Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks
Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)
Weight change from baseline at 12 weeks
Time frame: 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)
Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)
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