UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049823 |
|---|---|
| Receipt number | R000056742 |
| Scientific Title | The study of electroencephalogram during eating food with different quality. - crossover double-blind controlled trial- |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2023/12/25 09:29:14 |
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Basic information
Public title
Measurement of brain waves, etc. when eating chocolate with different properties.
Acronym
Effect of chocolate on brain waves.
Scientific Title
The study of electroencephalogram during eating food with different quality. - crossover double-blind controlled trial-
Scientific Title:Acronym
The study of electroencephalogram during eating food with different quality..
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the effects on physiological indices during and after chocolate consumption.
Basic objectives2
Others
Basic objectives -Others
Confirmation of changes in mood associated with eating chocolate and corresponding changes in physiological indices.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After wearing devices, EEG and autonomic nerve indices were measured at rest, while eating the test or control sample, and at rest after eating.
Based on the resting time before eating the sample, the difference between during and after eating the sample and between test or control sample are calculated for each index, and conduct an exploratory comparative study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test chocolate. There should be a washout period more than a day. Then, single intake of control chocolate.
Interventions/Control_2
Single intake of control chocolate. There should be a washout period more than a day. Then, single intake of test chocolate.
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) Healthy males and females whose age is no less than 20, less than 65 years old.
2) Subjects who don't dislike milk chocolate.
3) Subjects who can prohibit themselves from taking alcohol on the day before trial.
4) Subjects who can sleep enough on the day before trial and keep their regular conditions.
5) Subjects who finish eating 1.5 hours before the start of measurement on the day of the trial and can drink only water until the time of measurement.
6) Subjects who can prohibit the intake of caffeine, stimulants such as spices, and chocolate until the measurement time on the day of the trial.
Key exclusion criteria
1) Subjects with food allergies (milk and soy).
2) Subjects who moved or changed jobs between October 2022 and April 2023, or are planning to do so.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yuuichi |
| Middle name | |
| Last name | Maeda |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Future Value R&D Department, Core Technology Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0162
maeda_yuuichi@lotte.co.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ichikawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Future Value R&D Department, Core Technology Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0162
Homepage URL
ichikawa_tomoya@lotte.co.jp
Sponsor or person
Institute
LOTTE Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
LOTTE Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
PGV Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Shiba Palace clinic
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
株式会社ロッテ 中央研究所(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 20 | 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
35
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
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 23 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056742
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