UMIN-CTR Clinical Trial

Basic information
Public title	A study to investigate the impact of chocolate ingestion on brain function
Acronym	A study to investigate the impact of chocolate ingestion on brain function
Scientific Title	A study to investigate the impact of chocolate ingestion on brain function
Scientific Title:Acronym	A study to investigate the impact of chocolate ingestion on brain function
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess impact on brain function of intake chocolate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	MRI brain image
Key secondary outcomes	1)Specialized blood exam 2)Neuropsychological test(Paper based cognitive )tests 3)Subjective evaluation questionnaire

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	chocolate (8 weeks).
Interventions/Control_2	Placebo chocolate (8 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	45 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents. 2) Subjects who are healthy adults of both sexes above 45 years old- under 69 years old and live without receiving any care supports at the point of obtaining informed consent.
Key exclusion criteria	1) Subjects who metallic foreign bodies 2) Subjects who have history of head surgery (including childhood) 3) Subjects who have tattoo, permanent eye shadow, permanent eyebrow, and permanent eyelash extensions 4) Subjects who have history of occupational experience such as metallic abrasive, sheet-metal processing, welding, and lathe working 5) Subjects with claustrophobia 6) Subjects with nyctophobia 7) Subjects whose MMSE score is below 25 8) Subjects who are in pregnancy, lactation, or who are willing to become pregnant during this study 9) Subjects who are under treatment for chronic disorders 10) Subjects who cannot ingest aspartame L-phenylalanine compound (Subjects with phenylketonuria) 11) Subjects who participated in other clinical trial or monitor study within 1 month prior to screening 12) Subject with allergy to cacao, milk constituent and soy 13) Subjects with lactose intolerance 14) Subjects who highly intake cacao products on a daily basis (Cacao-rich chocolate: more than 70g/ week, Milk chocolate: more than 140g/ week) 15) Subjects who highly intake coffee on a daily basis (more than 3 cup of coffee/ day) 16) Subjects who intake medical chemical, quasi-drug, supplement, health food, foods for specified health use, foods with functions claims that potentially influence the outcome of this study, or subjects who plan to intake these during this study (such as health foods or supplement related to brain functions (including ginkgo leave extract, DHA and EPA) or health food containing high polyphenol (Tea of foods for specified health use(such as Iemon-Tokucha or Healthya Green Tea)) within 3 month prior to screening 17) Smokers (including subjects whose non-smoking period is less than 1 year) 18) Subjects who perform exercise more than 3 times a week * Exercise: Training exercise 19) Subjects who is ineligible for this study due to principal investigator's judgment
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kousuke Ozawa
Organization	Meiji Co., Ltd.
Division name	Chocolate & Cacao Technology Development Center Confectionery R&D Laboratories
Zip code
Address	6-1-2 Fujimi, Tsurugashima-shi, Saitama 350-2201, Japan
TEL	049-279-1448
Email	kousuke.ozawa@meiji.com

Public contact
1st name of contact person	1st name Middle name Last name Shigeru Imai
Organization	CROee.INC
Division name	Evidence Division
Zip code
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	CROee.INC
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
Address
Tel
Email

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	東京センタークリニック（東京都）、東京工業大学（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 30 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	132
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	2017 Year 08 Month 25 Day
Date of IRB	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 09 Month 24 Day
Last follow-up date	2018 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 29 Day
Last modified on	2019 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033047