The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure
CHOKO
1 other identifier
interventional
30
1 country
2
Brief 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. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 5, 2014
CompletedMay 5, 2014
May 1, 2014
1.2 years
May 1, 2014
May 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (2)
Ambulatory blood pressure
8 weeks
Blood lipids, inflammation markers, plasma levels of cocoa polyphenols
8 weeks
Study Arms (2)
Dark chocolate, dietary counselling
EXPERIMENTALMildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Dietary counselling
ACTIVE COMPARATORUsual snacks are limited.
Interventions
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Eligibility Criteria
You may qualify if:
- age 25-65 years
- resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
- BMI 25.0- 29.9
You may not qualify if:
- smoking
- regular medication for hypertension, cardiovascular disease, diabetes or asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- Fazer Groupcollaborator
Study Sites (2)
University of Helsinki
Helsinki, Helsingin Yliopisto, 00014, Finland
Institute of Clinical Medicine
Helsinki, Uusimaa, 00290, Finland
Related Publications (1)
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.
PMID: 26296850DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikael Fogelholm, Dr.
University of Helsinki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 5, 2014
Study Start
November 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 5, 2014
Record last verified: 2014-05