UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053295 |
|---|---|
| Receipt number | R000060607 |
| Scientific Title | Evaluation of the effect of consuming chocolate with breakfast on mood |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/09 11:38:40 |
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Basic information
Public title
Evaluation of the effect of consuming chocolate with breakfast on mood
Acronym
Evaluation of the effect of consuming chocolate with breakfast on mood
Scientific Title
Evaluation of the effect of consuming chocolate with breakfast on mood
Scientific Title:Acronym
Evaluation of the effect of consuming chocolate with breakfast on mood
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of consuming chocolate with breakfast on mood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
questionare on mood
Key secondary outcomes
amount of oxytocin in saliva
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 chocolate with breakfast
Interventions/Control_2
Not intake chocolate with breakfast
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Those who usually eat breakfast
2.Those who eat chocolates more than once in a year
3.Those who can come to the test institute for 2 consecutive mondays
4.Those who have holidays on saturdays and sundays
5.Those who have work in the morning after the test
Key exclusion criteria
1.Those with food allergy
2.Those with a past or current history of mental illness such as depression, bipolar disorder and sleep disorders
3.Those who use medicines, supllements or health foods for stress or sleep
4.Those who dislike milk chocolates
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Yamaguchi |
Organization
J. F. Oberlin University
Division name
College of Arts and Sciences
Zip code
194-0294
Address
Tokiwacho 3758, Machidashi, Tokyo, JAPAN
TEL
042-797-2661
y-hajime@obirin.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Shimada |
Organization
Platinum, Inc.
Division name
Consulting Division
Zip code
107-0052
Address
Akasaka Garden City 14F, 4-15-1, Akasaka, Minatoku, Tokyo, JAPAN
TEL
03-5572-6072
Homepage URL
m-shimada@vectorinc.co.jp
Sponsor or person
Institute
J. F. Oberlin University
Institute
Department
Personal name
Funding Source
Organization
Platinum, Inc.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
| 2024 | Year | 01 | Month | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060607
