NCT01659060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

July 31, 2012

Last Update Submit

August 2, 2012

Conditions

Hypertension Pregnancy-induced

Keywords

CacaoChocolateTheobromineFlavonoidsPregnant womenHypertension pregnancy-inducedPre-eclampsiaEpicatechin

Outcome Measures

Primary Outcomes (1)

  • Changes in endothelial function and blood pressure

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

Secondary Outcomes (3)

  • 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)

Study Arms (2)

Dark chocolate

EXPERIMENTAL
Other: Flavanol-rich dark chocolate

Placebo chocolate

PLACEBO COMPARATOR
Other: Placebo Chocolate

Interventions

Flavanol-rich dark chocolateOTHER

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.

Also known as: Chocolate rich in flavanols
Dark chocolate
Placebo ChocolateOTHER

Placebo intervention

Also known as: Flavanol-free chocolate
Placebo chocolate

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • Mogollon JA, Bujold E, Lemieux S, Bourdages M, Blanchet C, Bazinet L, Couillard C, Noel 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;12:41. doi: 10.1186/1475-2891-12-41.

    PMID: 23565841DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Sylvie Dodin, MD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 7, 2012

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

CA(1)