UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028364 |
|---|---|
| Receipt number | 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 12:17:44 |
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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
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
chisamatsumoto@post.harvard.edu
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022497
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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