UMIN-CTR Clinical Trial

Basic information
Public title	Study for Anti-fatigue effect of chocolate
Acronym	Study for Anti-fatigue effect of chocolate
Scientific Title	Study for Anti-fatigue effect of chocolate
Scientific Title:Acronym	Study for Anti-fatigue effect of chocolate
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the fatigue-reducing effect of chocolate intake on fatigue caused by mental workload.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Fatigue evaluation -Saliva test -Calculation task
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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 chocolate and water Washout for 1day or more Intake of water
Interventions/Control_2	Intake of water Washout for 1day or more Intake of chocolate and water
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. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Persons who are 20 years old or more and under 65 years old, Male and Female
Key exclusion criteria	1. Persons who have chronic illness, receiving medication 2. Persons who are allergic to rice, cacao, milk ingredient and soy 3. Persons who are unable to ingest high cacao chocolate 4. Persons who have participated in other tests (Excluding observational research) within the first month before the start of the exam, or who are planning to participate in other tests from after this exam consent to the end of this exam 5. Persons who are breast-feeding, pregnant, and are planning pregnancy during the exam 6. Persons who are judged ineligible at the discretion of the principal investigator and sub-investigator
Target sample size	30

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, Hachiouji, Tokyo
TEL	042-632-5850
Email	midori.natsume@meiji.com

Public contact
Name of contact person	1st name Hirohito Middle name Last name Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	ishikawa@hc-sys.jp

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Healthcare Systems Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
Tel	042-632-5900
Email	MEIJI.IRB@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	2019 Year 10 Month 28 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	29
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 10 Month 18 Day
Date of IRB	2019 Year 10 Month 18 Day
Anticipated trial start date	2019 Year 10 Month 29 Day
Last follow-up date	2019 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 25 Day
Last modified on	2020 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043743