UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036746
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email akihiro.sasaki@riken.jp

Sponsor
Institute RIKEN
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.