UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058734 |
|---|---|
| Receipt number | R000067161 |
| Scientific Title | Safety evaluation of excessive intake of dark chocolate |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 11:16:39 |
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Basic information
Public title
Safety evaluation of excessive intake of dark chocolate
Acronym
Safety evaluation of excessive intake of dark chocolate
Scientific Title
Safety evaluation of excessive intake of dark chocolate
Scientific Title:Acronym
Safety evaluation of excessive intake of dark chocolate
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake at three times the recommended daily intake of dark chocolate for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview (before and 2, 4 weeks after intake and 2 weeks after the end of intake period),
Adverse events (thorough the study)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of dark chocolate at three times the recommended daily amount, for 4 weeks
Interventions/Control_2
Intake of placebo chocolate at three times the recommended daily amount, for 4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 to 64 years at the time of obtaining consent
2) Ambulatory blood pressure values at the time of the pre-test that meet one of the following criteria:
a) Higher blood pressure (Systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)
b) Normal blood pressure
3) Subjects who fully understand the purpose and details of the study and voluntarily consent to participate
Key exclusion criteria
1) Subjects who had exhibited abnormal clinical laboratory values in the past and were judged to be unsuitable for participation in the study
2) Subjects with a current or past medical history of serious diseases such as brain disorders, malignant tumors, immune disorders, kidney disorders, liver disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, or other metabolic disorders
3) Subjects with food allergies
4) Subjects with chronic internal medical conditions requiring continuous treatment (whether topical or oral), those currently undergoing treatment for chronic internal diseases, or those with a history of serious illness requiring medication
5) Subjects with significantly abnormal values deviating from the reference range in physical measurements, physical examinations, or clinical laboratory tests prior to intake
6) Subjects who work in shifts or late at night, and have irregular daily routines or eating habits
7) Subjects who have participated in other clinical studies within one month prior to the start of this study, are currently participating, or wish to participate in such studies during the study period
8) Subjects who plan to become pregnant or breastfeed during the study period
9) Subjects who cannot ingest chocolate daily
10) Subjects who consume foods, beverages, or supplements high in cacao flavanols and cannot discontinue their consumption during the study period
11) Subjects with a current or past medical history of drug or alcohol dependence
12) Heavy alcohol drinkers (average pure alcohol intake of approximately 41 g/day or more)
13) Subjects who plan to travel overseas during the study period
14) Subjects who are judged to be unsuitable based on their responses to the background survey
15) Subjects who are judged unsuitable for the study by the principal investigator for other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.jp
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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | 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 | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067161
