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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Hypertension | |
Classification by specialty |
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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)
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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 |
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Interventions/Control_1 | Dark chocolate 24g per day
14.4 g in the morning and 9.6 g in the evening duration 4weeks |
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Interventions/Control_2 | White chocolate 24g per day
14.4 g in the morning and 9.6 g in the evening duration 4weeks |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Tokyo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Morinaga, Co., Ltd., Japan |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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IRB Contact (For public release) | |
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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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |