UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050837 |
|---|---|
| Receipt number | R000057861 |
| Scientific Title | A Study of Long-Term Consumption of Plant-Derived Products on sleep -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/07/10 13:43:06 |
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Basic information
Public title
A Study of Long-Term Consumption of Plant-Derived Products on sleep
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study of Long-Term Consumption of Plant-Derived Products on sleep
Scientific Title
A Study of Long-Term Consumption of Plant-Derived Products on sleep
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study of Long-Term Consumption of Plant-Derived Products on sleep
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of long-term consumption of plant-derived products on sleep.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleeping Questionnaire
Key secondary outcomes
Sleep-Related 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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Plant-Derived Products, 4 weeks consumption
Interventions/Control_2
Placebo Products, 4 weeks consumption
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 Japanese males and females aged 20 to 64 years-old.
2) Subjects who have some sleep problems.
3) Subjects who defecate three to five a week.
4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1) contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
2) have a chronic disease and use medications.
3) have a history and/or a surgical history of digestive disease affecting digestion and absorption.
4) use medications, functional foods, or supplements affecting sleep or stress.
5) drink excessive alcohol.
6) can't stop drinking from one day before each measurement (day before the sleep survey recording date).
7) with a history of and/or current mental illness associated with sleep disorder.
8) with a history of and/or current mental illness associated with sleep disorder.
9) sleeping with their family in the same room, and might be woken up by the family during sleep.
10) plan to go on a business trip (domestic or overseas) or trip (domestic or overseas) during the study period.
11) can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation and/or containing a large amount of sugar alcohol during this study.
12) regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation.
13) have declared allergic reaction to ingredients of test foods.
14) are under treatment for or have a history of drug addiction and/or alcoholism.
15) are pregnant or breastfeed or planning to become pregnant.
16) with extremely irregular dietary habit and/or irregular sleep hours and sleep habits due to irregular shift work, late night work, etc.
17) are participating in or willing to participate in other clinical studies.
18) are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
University of Nagasaki
Division name
Regional Partnership Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Nakamura |
Organization
University of Nagasaki
Division name
General Affairs and Planning Division
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5500
Homepage URL
k_nakamura@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
University of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
Tel
095-813-5500
k_nakamura@sun.ac.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 | 14 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | 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 | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057861
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