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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028364
Receipt No. R000022497
Scientific Title Effect of Dark Chocolate on Home Blood Pressure
Date of disclosure of the study information 2017/07/25
Last modified on 2017/07/25

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Basic information
Public title Effect of Dark Chocolate on Home Blood Pressure
Acronym DCHBP
Scientific Title Effect of Dark Chocolate on Home Blood Pressure
Scientific Title:Acronym DCHBP
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previous studies have reported a beneficial effect of dark chocolate (DC) on casual blood pressure (cBP). DC may also have favorable effects on vascular function and insulin sensitivity (IS), which are strongly correlated with the progression of hypertension. However, the mechanism of the BP-lowering effect of DC has not been fully clarified. Home blood pressure (HBP) is regarded as a more plausible method of evaluating the severity of hypertension, compared with cBP, and its day-to-day variability associated with vascular dysfunction is regarded as an important predictor of future cardiovascular disease beyond the average HBP itself. To assess HBP, tele-monitoring is a reliable method. However, the effects of DC on HBP tele-monitoring results, HBP variability, vascular functions, and IS have not been comprehensively examined as part of studies to evaluate the underlying mechanism of the BP-lowering effects of DC and the potential effect modifications between DC and IS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes home blood pressure(HBP), HBP variability, vasculare function, insulin sensitivity (IS)
Key secondary outcomes interaction between DC and IS

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Dark chocolate 24g per day
14.4 g in the morning and 9.6 g in the evening
duration 4weeks
Interventions/Control_2 White chocolate 24g per day
14.4 g in the morning and 9.6 g in the evening
duration 4weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Twenty apparently healthy men and women aged 40-65 years with a high normal BP or mild hypertension ) who were not receiving antihypertensive treatment were enrolled in this study
Key exclusion criteria History of CVD, malignant disease, or other chronic disease including CVD risk factors other than mild hypertension (i.e., dyslipidemia, diabetes mellitus, and chronic kidney disease), BMI mor than 30 kg/m2, current smoker, habitual use of antioxidant supplements, milk or chocolate or cacao allergy, and premenopausal
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Tomiyama
Organization Tokyo Medical University
Division name Department of Cardiology
Zip code
Address 6-1-1 Nishishinjyuku Shinjyukuku, Tokyo, Japan
TEL 03-3342-6111
Email tomiyama@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chisa Matsumoto
Organization Tokyo Medical University
Division name Department of Cardiology
Zip code
Address 6-1-1 Nishishinjyuku Shinjyukuku, Tokyo, Japan
TEL 03-3342-6111
Homepage URL
Email chisamatsumoto@post.harvard.edu

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Morinaga, Co., Ltd., Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 25 Day
Last follow-up date
2015 Year 10 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 25 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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