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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028880
Receipt No. R000033047
Scientific Title A study to investigate the impact of chocolate ingestion on brain function
Date of disclosure of the study information 2017/08/30
Last modified on 2019/04/22

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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