Blood PressureCHOKONCT02130141
The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure
A study testing Dark chocolate and Dietary counselling in people with Blood Pressure, run by University of Helsinki at 2 sites in Finland.
Trial summary
The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Dark chocolate and Dietary counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFinland
- Study dates
- Nov 2012to Jan 2014
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 25-65 years
- resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
- BMI 25.0- 29.9
Who cannot join
- smoking
- regular medication for hypertension, cardiovascular disease, diabetes or asthma
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
University of Helsinki
Helsinki, Helsingin Yliopisto, 00014
Institute of Clinical Medicine
Helsinki, Uusimaa, 00290
About this study
Official title: The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals
The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.
- Conditions
- Blood Pressure
- Being tested
- Dark chocolate, Dietary counselling
- Keywords
- cocoa, dark chocolate, hypertension, blood pressure monitoring, ambulatory, flavanols
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolateDietary supplement
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Dietary counsellingOther
Usual snacks are limited.
| Study group | Role | What they receive |
|---|---|---|
| Dark chocolate, dietary counselling | Experimental | Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks. Receives: Dietary Supplement: Dark chocolate |
| Dietary counselling | Active comparator | Usual snacks are limited. Receives: Dietary Supplement: Dark chocolate; Other: Dietary counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic and diastolic blood pressure
Usual daily snack is replaced by 50 g dark chocolate for a period of 8 weeks. During the control period, the same usual snack is limited in the diet, but without the replacement with the dark chocolate.
Measured: 8 weeks
Secondary outcomes (2)
Ambulatory blood pressure
Measured: 8 weeks
Blood lipids, inflammation markers, plasma levels of cocoa polyphenols
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJan 2014
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 Blood PressureStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Fazer Group
- Responsible party
- Principal investigator, Mikael Fogelholm, University of Helsinki
- Investigators
- Mikael Fogelholm, Dr., Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130141
- Sponsor's protocol ID
- HY-RAV-FAZ-01
- Acronym
- CHOKO
- Status last verified
- May 2014
- First submitted
- 1 May 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Koli R, Kohler K, Tonteri E, Peltonen J, Tikkanen H, Fogelholm M. Dark chocolate and reduced snack consumption in mildly hypertensive adults: an intervention study. Nutr J. 2015 Aug 22;14:84. doi: 10.1186/s12937-015-0075-3.
PubMed 26296850
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT02130141
- Acronym / sponsor ID
- CHOKO / HY-RAV-FAZ-01
- Conditions
- Blood Pressure
- Keywords
- cocoa, dark chocolate, hypertension, blood pressure monitoring, ambulatory, flavanols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Fazer Group
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 May 2014 (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 evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark chocolate, dietary counselling | Experimental | Dietary Supplement: Dark chocolateMildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks. |
| Dietary counselling | Active comparator | Dietary Supplement: Dark chocolate, Other: Dietary counsellingUsual snacks are limited. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 25-65 years
- resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
- BMI 25.0- 29.9
Key exclusion criteria (2 listed)
- smoking
- regular medication for hypertension, cardiovascular disease, diabetes or asthma
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 |
|---|---|---|
| Dark chocolateMildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks. | Dietary supplement | Dark chocolate, dietary counselling, Dietary counselling |
| Dietary counsellingUsual snacks are limited. | Other | Dietary counselling |
Primary outcome
Changes in systolic and diastolic blood pressure
Time frame: 8 weeks
Usual daily snack is replaced by 50 g dark chocolate for a period of 8 weeks. During the control period, the same usual snack is limited in the diet, but without the replacement with the dark chocolate.
2 secondary outcomes
Ambulatory blood pressure
Time frame: 8 weeks
Blood lipids, inflammation markers, plasma levels of cocoa polyphenols
Time frame: 8 weeks
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 5 May 2014.
- Derived from this study: PubMed 26296850Koli R, Kohler K, Tonteri E, Peltonen J, Tikkanen H, Fogelholm M. Dark chocolate and reduced snack consumption in mildly hypertensive adults: an intervention study. Nutr J. 2015 Aug 22;14:84. doi: 10.1186/s12937-015-0075-3.
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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.
Mikael Fogelholm, Dr. principal investigator
University of Helsinki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark chocolate and Dietary counselling in people with Blood Pressure, run by University of Helsinki at 2 sites in Finland.
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 3 inclusion and 2 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 systolic and diastolic blood pressure (time frame: 8 weeks). 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 NCT02130141, 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 5 May 2014.