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Completed

NCT Number: NCT01659060

Chocolate Consumption in Healthy Pregnant Women 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.

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Key information

Conditions

Hypertension Pregnancy-induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flavanol-rich dark chocolate

Other

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 Chocolate

Other

Placebo intervention

Other names: Flavanol-free chocolate

Primary outcomes

  1. Changes in endothelial function and blood pressure

    Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)

Secondary outcomes

  1. 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)

  2. Weight change from baseline at 12 weeks

    Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)

  3. 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)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2012
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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