UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053491 |
|---|---|
| Receipt number | R000061056 |
| Scientific Title | The effect of ingestion of cocoa flavanols on blood pressure - A systematic review |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/06/05 10:10:20 |
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Basic information
Public title
The effect of ingestion of cocoa flavanols on blood pressure - A systematic review
Acronym
Effect of cocoa flavanols on blood pressure - A systematic review
Scientific Title
The effect of ingestion of cocoa flavanols on blood pressure - A systematic review
Scientific Title:Acronym
Effect of cocoa flavanols on blood pressure - A systematic review
Region
| Japan |
Condition
Condition
Healthy (including normotensive subjects) and Grade I Hypertension adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of ingestion of cocoa flavanols on blood pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure(systolic blood pressure, diastolic blood pressure)
Key secondary outcomes
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
Healthy(including normotensive subjects)and Grade I Hypertension adults
Key exclusion criteria
Sufferers from illness except Grade I Hypertension, persons under 18 years and pregnant women
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Natsume |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
midori.natsume@meiji.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Natsume |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
Homepage URL
midori.natsume@meiji.com
Sponsor or person
Institute
Yakujihou Marketing Jimusho Inc.
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
N/A
Address
N/A
Tel
042-632-5847
midori.natsume@meiji.com
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
| 2024 | Year | 02 | Month | 01 | 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
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.This research review will be conducted in accordance with PRISMA 2020
2.For systematic reviews, there is no approval by an IRB. The date of IRB was entered as the date of protocol fixation.
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061056
