UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059995 |
|---|---|
| Receipt number | R000068615 |
| Scientific Title | Systematic Review and Meta-Analysis on the Effects of Cocoa Flavanol Intake on Blood Pressure and Its Implications for Cardiovascular Disease Risk Reduction |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 14:56:16 |
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Basic information
Public title
Systematic Review and Meta-Analysis on the Effects of Cocoa Flavanol Intake on Blood Pressure and Its Implications for Cardiovascular Disease Risk Reduction
Acronym
Systematic Review and Meta-Analysis on the Effects of Cocoa Flavanol Intake on Blood Pressure and Its Implications for Cardiovascular Disease Risk Reduction
Scientific Title
Systematic Review and Meta-Analysis on the Effects of Cocoa Flavanol Intake on Blood Pressure and Its Implications for Cardiovascular Disease Risk Reduction
Scientific Title:Acronym
Systematic Review and Meta-Analysis on the Effects of Cocoa Flavanol Intake on Blood Pressure and Its Implications for Cardiovascular Disease Risk Reduction
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to comprehensively analyze the effects of cocoa flavanol intake on blood pressure and to clarify its association with cardiovascular disease (CVD) risk reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic blood pressure and diastolic blood pressure
Key secondary outcomes
Flow-mediated dilation, pulse wave velocity and ankle-brachial index
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Interventional studies involving healthy adults or individuals with hypertension, including stage 1 to 3 hypertension.
Studies that report blood pressure (systolic and/or diastolic) as a primary or secondary outcome.
Randomized controlled trials (RCTs) with placebo or non-intake control groups.
Key exclusion criteria
Studies involving minors or pregnant and lactating women.
Studies using an intervention product where the specific content of cacao flavanols is not specified.
Studies using an intervention product that contains ingredients, other than cacao flavanols, which could potentially affect blood pressure.
Studies using a control product that contains ingredients which could potentially affect blood pressure.
Studies that include co-interventions, such as dietary modifications or exercise, which could potentially affect blood pressure.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Watanabe |
Organization
Yakujihou Marketing Jimusho Co., Ltd.
Division name
None
Zip code
100-6162
Address
3rd Floor, Sanno Park Tower, 2-11-1 Nagatacho, Chiyoda-ku, Tokyo 100-6162, Japan
TEL
03-6205-3546
watanabe@yakujihou-marketing.co.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Watanabe |
Organization
Yakujihou Marketing Jimusho Co., Ltd.
Division name
None
Zip code
100-6162
Address
3rd Floor, Sanno Park Tower, 2-11-1 Nagatacho, Chiyoda-ku, Tokyo 100-6162, Japan
TEL
03-6205-3546
Homepage URL
watanabe@yakujihou-marketing.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
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
Not applicable (Systematic review)
Address
Not applicable (Systematic review)
Tel
Not applicable (Systematic review)
Not applicable (Systematic review)
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
| 2025 | Year | 12 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research review will be conducted in accordance with PRISMA2020
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068615
