Hypertension Pregnancy-inducedPhase 2NCT01659060
Chocolate Consumption in Healthy Pregnant Women Trial
A Phase 2 study testing Flavanol-rich dark chocolate in people with Hypertension Pregnancy-induced, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hypertension Pregnancy-induced
- What is being tested?
- Flavanol-rich dark chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Apr 2009
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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: 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.
- Conditions
- Hypertension Pregnancy-induced
- Being tested
- Flavanol-rich dark chocolate, Placebo Chocolate
- Keywords
- Cacao, Chocolate, Theobromine, Flavonoids, Pregnant women, Hypertension pregnancy-induced, Pre-eclampsia, Epicatechin
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol-rich dark chocolateOther
Also called Chocolate rich in flavanols
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 ChocolateOther
Also called Flavanol-free chocolate
Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Dark chocolate | Experimental | Not described Receives: Other: Flavanol-rich dark chocolate |
| Placebo chocolate | Placebo comparator | Not described 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 and blood pressure
Measured: 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
Measured: within the first 12 weeks of chocolate intake (week 12 and baseline)
Weight change from baseline at 12 weeks
Measured: 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)
Measured: within the first 12 weeks of chocolate intake (week 12 and baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension Pregnancy-inducedStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 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
- NCT01659060
- Sponsor's protocol ID
- 119.05.03
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23565841
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01659060
- Acronym / sponsor ID
- 119.05.03
- Conditions
- Hypertension Pregnancy-induced
- Keywords
- Cacao, Chocolate, Theobromine, Flavonoids, Pregnant women, Hypertension pregnancy-induced, Pre-eclampsia, Epicatechin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Aug 2012 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark chocolate | Experimental | Other: Flavanol-rich dark chocolate |
| Placebo chocolate | Placebo comparator | Other: Placebo Chocolate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 dark chocolateAlso: Chocolate rich in flavanolsThe 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 | Dark chocolate |
| Placebo ChocolateAlso: Flavanol-free chocolatePlacebo intervention | Other | Placebo chocolate |
Primary outcome
Changes in endothelial function and blood pressure
Time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)
3 secondary outcomes
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)
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 7 Aug 2012.
- Derived from this study: PubMed 23565841Mogollon 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.
Related trials for Hypertension Pregnancy-induced
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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
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
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 dark chocolate in people with Hypertension Pregnancy-induced, 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 1 inclusion and 6 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 7 Aug 2012. 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 and blood pressure (time frame: within the first 12 weeks of chocolate intake (week 12 and baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659060, which also lists 1 linked publication.
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 7 Aug 2012.