UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050895 |
|---|---|
| Receipt number | R000057948 |
| Scientific Title | Evaluation of Efficacy of Test Food on Behavior Changes in Healthy Adults living in Kashiwanoha Smart City -A Randomized, Double-Blind, Placebo-Controlled Crossover and Parallel-Group Trial- |
| Date of disclosure of the study information | 2023/04/21 |
| Last modified on | 2023/04/20 16:08:15 |
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Basic information
Public title
Evaluation of Efficacy of Test Food on Behavior Changes in Healthy Adults living in Kashiwanoha Smart City -A Randomized, Double-Blind, Placebo-Controlled Crossover and Parallel-Group Trial-
Acronym
Evaluation of Efficacy of Test Food on Behavior Changes in Healthy Adults living in Kashiwanoha Smart City -A Randomized, Double-Blind, Placebo-Controlled Crossover and Parallel-Group Trial-
Scientific Title
Evaluation of Efficacy of Test Food on Behavior Changes in Healthy Adults living in Kashiwanoha Smart City -A Randomized, Double-Blind, Placebo-Controlled Crossover and Parallel-Group Trial-
Scientific Title:Acronym
Evaluation of Efficacy of Test Food on Behavior Changes in Healthy Adults living in Kashiwanoha Smart City -A Randomized, Double-Blind, Placebo-Controlled Crossover and Parallel-Group Trial-
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy of test food on behavior changes in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation of activity ratio within 24 hours
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group 1a
Starting from placebo and switching placebo and test food every 4 weeks
(48 weeks in total)
Interventions/Control_2
Group 1b
Starting from test food and switching test food and placebo every 4 weeks
(48 weeks in total)
Interventions/Control_3
Group 2a
Starting from placebo and switching placebo and test food every 12 weeks
(48 weeks in total)
Interventions/Control_4
Group 2b
Starting from test food and switching test food and placebo every 12 weeks
(48 weeks in total)
Interventions/Control_5
Group 3a
Starting from placebo and switching placebo and test food every 24 weeks
(48 weeks in total)
Interventions/Control_6
Group 3b
Starting from test food and switching test food and placebo every 24 weeks
(48 weeks in total)
Interventions/Control_7
Group 4a
placebo (48 weeks in total)
Interventions/Control_8
Group 4b
test food (48 weeks in total)
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects who live in Kashiwanoha Smart City
2)Subjects who voluntarily give written informed consent
3)Healthy subjects who are aged 20-59
4)Subjects who can participate in dietary interventions, intake of test foods, blood samplings, urine samplings, and fecal samplings as scheduled
Key exclusion criteria
1)Subjects whose blood test results are judged to be ineligible for this study by lead principal investigator
2)Subjects who had a history of GI disorders and cardiovascular disorders, or who had a history of treatments by doctors for more than 1 months
3)Subjects with allergies
4)Subjects who used antibiotics within last one month prior to fecal samplings
5)Subjects who underwent GI tract surgery in the past half year
6)Subjects who are participating in other clinical studies or who are planning to participate in other clinical studies
7)Subjects who are during lactation and pregnancy or who wish to get pregnant
8)Subjects who are judged to be ineligible for this study by lead principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, 520-0002
TEL
+81-77-521-8835
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ueda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga, 520-0002
TEL
+81-77-521-8835
Homepage URL
Ueda.Atsushi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitsui Fudosan Co., Ltd.
TechDoctor, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1499
shimizu_se@otsuka.jp
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
| 2023 | Year | 04 | Month | 21 | 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 | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057948
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| Registered date | File name |
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