UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039660 |
|---|---|
| Receipt number | R000045238 |
| Scientific Title | Examination of the effects and timing of Test Diet intake on the subjective well-being bodily |
| Date of disclosure of the study information | 2020/03/22 |
| Last modified on | 2020/09/30 14:03:43 |
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Basic information
Public title
Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Acronym
Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Scientific Title
Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Scientific Title:Acronym
Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects and timing of Test Diet intake on subjective well being
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaires for subjective well-being or other QOL scales
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
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval)
2.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval)
3.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
4.take a placebo after breakfast and dinner (Intake for 2 weeks)
Interventions/Control_2
1.take a placebo food after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
2.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval)
3.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval)
4.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (Intake for 2 weeks)
Interventions/Control_3
1.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
2.take a placebo after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
3.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval)
4.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (Intake for 2 weeks)
Interventions/Control_4
1.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval)
2.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
3.take a placebo after breakfast and dinner (After intake for 2 weeks, 2 weeks interval)
4.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (Intake for 2 weeks)
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)Subjects of both sexes above 20 years old- under 65 years old
2)Subjects who can answer on-line questionnaire by smartphone or iPhone
3)Subjects who give consent
Key exclusion criteria
1)Subjects who are under pharmacological treatment for chronic disorders, especially subjects who take Warfarin
2)Subjects who have histories of mental disorders (Depression etc.)
3)Subjects who work irregular hours on the night shift or irregular shift
4)Subjects who had participated in other clinical trials or monitoring studies within 1 month
5)Subjects who have intolerance to study food substance
6)Subjects who are in pregnancy, lactation, or who are willing to become pregnant
7)Subjects who are ineligible due to the chief inspector's judgment
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
euglena Co., Ltd.
Division name
Advanced Technology Research Department Functionality Research Section
Zip code
108-0014
Address
Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL
03-3453-4907
nakashima@euglena.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
105-0004
Address
Shinbashi 2-16-1 Minato-ku, Tokyo 105-0004, Japan
TEL
080-7290-0404
Homepage URL
https://www.levbrain.com
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
euglena 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.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
| 2020 | Year | 03 | Month | 22 | 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
36
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
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045238
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