UMIN-CTR Clinical Trial

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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