UMIN-CTR Clinical Trial

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