UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028880 |
|---|---|
| Receipt number | 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 11:17:34 |
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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
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
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033047
