UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036746 |
|---|---|
| Receipt number | R000041652 |
| Scientific Title | Exploratory study on effect of cacao intake on human brain function: single blind - investigators and assessors blind - cross over comparison study. |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/05/25 14:24:32 |
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Basic information
Public title
Exploratory study on effect of cacao intake on human brain function: single blind - investigators and assessors blind - cross over comparison study.
Acronym
Exploratory study on effect of cacao intake on human brain function
Scientific Title
Exploratory study on effect of cacao intake on human brain function: single blind - investigators and assessors blind - cross over comparison study.
Scientific Title:Acronym
Exploratory study on effect of cacao intake on human brain function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of single ingestion of cacao products on subjective feelings (fatigue, stress, boring, sleepiness, motivation, healng, joy, relax, and concentration), autonomic nervous function, and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of cognitive task performance at the period from 5 to 15 minutes after test food ingestion and from 30 to 45 minutes after test food ingestion.
Key secondary outcomes
Comparison of subjective feelings, measured by visual analog scale, before and after test food ingestion.
Comparison of autonomic nervous function before and after test food ingestion.
Number of side effect in 24 hours after test food ingestion.
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food 1-> Washout (3 days or more) -> Single ingestion of test food 2
Interventions/Control_2
Single ingestion of test food 2-> Washout (3 days or more) -> Single ingestion of test food 1
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individual who has received sufficient explanation about purpose and content of research, and consenting ability, and who volunteers with his/her free intent and gives written informed consent.
Key exclusion criteria
(1) Individual who has been taken medications, quasi-drugs (excluding topical drugs) and supplements for more than 5 days a week within a month before screening test, or who plans to take those for more than 5 days a week during research period.
(2) Individual who has a serious disease such as cranial nerve disease, liver disease, kidney disease, heart disease, cardiovascular disease, malignancy, or who has history of that.
(3) Individual who has nervous seizure (such as Loss of consciousness, coma, convulsions), color blindness, diabetes, or arrhythmia, or who has history of that.
(4) Individual who has dysfunction of autonomic nervous system (whose value of LF/HF is more than 10 on the screening test).
(5) Individual who has food allergy
(6) Individual who can not intake bitter chocolate (dark chocolate) (*1)
(7) Individual who consume excessive alcohol (average of 60 g/day or more in alcohol equivalent)
(8) Individual who has a smoking habit
(9) Individual who have day and night shift work and night work
(10) Individual has poor performance, less than 50% correct answer rate) in the cognitive function task (confirmation of answer ability) at the screening test.
(11) Individual who has participated in other clinical research within a month before the research, or plan to participate that during the study period.
(12) Individual who is pregnant, possibly pregnant, or breastfeeding, or who has plan or wish for pregnancy during the study period.
(13) Individual whom principal investigator or sub-investigator judged to be inappropriate as a subject.
*1. Bitter (or dark) chocolate refers to chocolate with 40-60 % cacao mass containing no milk (or milk component), chocolate with low sugar or milk content and high bitterness, and chocolate with 70-90% cacao content and low sugar.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Sasaki |
Organization
RIKEN Center for Biosystems Dynamics Research
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo, Japan
TEL
81-78-569-8868
akihiro.sasaki@riken.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Sasaki |
Organization
RIKEN Center for Biosystems Dynamics Research
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo, Japan
TEL
81-78-569-8868
Homepage URL
akihiro.sasaki@riken.jp
Sponsor or person
Institute
RIKEN
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
RIKEN Kobe Institute Safety Center
Address
-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
Tel
078-306-3036
kobe-ankan@cdb.riken.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
22
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
| 2019 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 22 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041652
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