PreeclampsiaPhase 2CHOCENTANCT01431443
Consumption of Chocolate in Pregnant Women.
A Phase 2 study testing Flavanol-rich chocolate in people with Preeclampsia, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Flavanol-rich chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between the ages of 18 and 40 years.
- Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.
Who cannot join
- Hypertension requiring medication.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
Québec, Quebec, G1V 0A6
About this study
Official title: Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.
The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.
Read the detailed description
Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.
The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.
- Conditions
- Preeclampsia
- Being tested
- Flavanol-rich chocolate, Placebo Chocolate
- Keywords
- Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol-rich chocolateOther
The aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia.
Placebo ChocolateOther
Also called Flavanol and theobromine-free chocolate
Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Dark chocolate | Experimental | Not described Receives: Other: Flavanol-rich chocolate |
| Placebo chocolate | Placebo comparator | Placebo intervention Receives: Other: Placebo Chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelial function
Measured: within the first 12 weeks of chocolate intake
Secondary outcomes (4)
Doppler of uterine arteries
Measured: within the first 12 weeks of chocolate intake
Blood pressure
Measured: within the first 12 weeks of chocolate intake
Plasma biomarker of endothelium function
Measured: within the first 12 weeks of chocolate intake
Plasma biomarker of chocolate intake
ng\ml plasma
Measured: within the first 12 weeks of chocolate intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Dodin, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431443
- Sponsor's protocol ID
- IC096501
- Acronym
- CHOCENTA
- Status last verified
- Apr 2015
- First submitted
- 2 May 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.
- ClinicalTrials.gov ID
- NCT01431443
- Acronym / sponsor ID
- CHOCENTA / IC096501
- Conditions
- Preeclampsia
- Keywords
- Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.
Detailed description
Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.
The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark chocolate | Experimental | Other: Flavanol-rich chocolate |
| Placebo chocolate | Placebo comparator | Other: Placebo ChocolatePlacebo intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women between the ages of 18 and 40 years.
- Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.
Key exclusion criteria (5 listed)
- Hypertension requiring medication.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavanol-rich chocolateThe aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia. | Other | Dark chocolate |
| Placebo ChocolateAlso: Flavanol and theobromine-free chocolatePlacebo intervention | Other | Placebo chocolate |
Primary outcome
Changes in endothelial function
Time frame: within the first 12 weeks of chocolate intake
4 secondary outcomes
Doppler of uterine arteries
Time frame: within the first 12 weeks of chocolate intake
Blood pressure
Time frame: within the first 12 weeks of chocolate intake
Plasma biomarker of endothelium function
Time frame: within the first 12 weeks of chocolate intake
Plasma biomarker of chocolate intake
Time frame: within the first 12 weeks of chocolate intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Dodin, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flavanol-rich chocolate in people with Preeclampsia, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in endothelial function (time frame: within the first 12 weeks of chocolate intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.