The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure

Blood Pressure Clinical Trial

— CHOKO  

Official title:

The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130141
• Other study ID #: HY-RAV-FAZ-01
• Status: Completed
• Phase: N/A
• First received: May 1, 2014
• Last updated: May 1, 2014
• Start date: November 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical 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. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 25-65 years

• resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg

• BMI 25.0- 29.9

Exclusion Criteria:

• smoking

• regular medication for hypertension, cardiovascular disease, diabetes or asthma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Dietary Supplement:
• Dark chocolate
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.

Other:
• Dietary counselling
Usual snacks are limited.

Locations

Country	Name	City	State
Finland	Institute of Clinical Medicine	Helsinki	Uusimaa
Finland	University of Helsinki	Helsinki	Helsingin Yliopisto

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Fazer Group

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ambulatory blood pressure		8 weeks	No
Secondary	Blood lipids, inflammation markers, plasma levels of cocoa polyphenols		8 weeks	No