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Chocolate Consumption in Healthy Pregnant Women Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01659060
First received: July 31, 2012
Last updated: August 2, 2012
Last verified: August 2012

July 31, 2012
August 2, 2012
July 2008
April 2009   (final data collection date for primary outcome measure)
Changes in endothelial function and blood pressure [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01659060 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • Weight change from baseline at 12 weeks [ Time Frame: within the first 12 weeks of chocolate intake (week 12 and baseline) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Hypertension Pregnancy-induced
  • 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 Name: Chocolate rich in flavanols
  • Other: Placebo Chocolate
    Placebo intervention
    Other Name: Flavanol-free chocolate
  • Experimental: Dark chocolate
    Intervention: Other: Flavanol-rich dark chocolate
  • Placebo Comparator: Placebo chocolate
    Intervention: Other: Placebo Chocolate
Mogollon JA, Bujold E, Lemieux S, Bourdages M, Blanchet C, Bazinet L, Couillard C, Noël M, Dodin S. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial. Nutr J. 2013 Apr 8;12(1):41. doi: 10.1186/1475-2891-12-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01659060
119.05.03
Yes
Laval University
Laval University
Not Provided
Principal Investigator: Sylvie Dodin, MD Laval University
Laval University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP