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

NCT ID: NCT02130141

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dark chocolate, dietary counselling

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

Group Type EXPERIMENTAL

Dark chocolate

Intervention Type DIETARY_SUPPLEMENT

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

Dietary counselling

Usual snacks are limited.

Group Type ACTIVE_COMPARATOR

Dark chocolate

Intervention Type DIETARY_SUPPLEMENT

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

Dietary counselling

Intervention Type OTHER

Usual snacks are limited.

Interventions

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Dark chocolate

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

Intervention Type DIETARY_SUPPLEMENT

Dietary counselling

Usual snacks are limited.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fazer Group

INDUSTRY

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Mikael Fogelholm

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikael Fogelholm, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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University of Helsinki

Helsinki, Helsingin Yliopisto, Finland

Site Status

Institute of Clinical Medicine

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 26296850 (View on PubMed)

Other Identifiers

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HY-RAV-FAZ-01

Identifier Type: -

Identifier Source: org_study_id

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