UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025723 |
|---|---|
| Receipt number | R000029579 |
| Scientific Title | Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/01/18 10:47:12 |
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Basic information
Public title
Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Acronym
Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Scientific Title
Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Scientific Title:Acronym
Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Region
| Japan |
Condition
Condition
Psychiatric disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of the Pittsburgh sleep questionnaire Japanese edition (PSQI-J), at 0, 4 and 8 weeks after test start
Key secondary outcomes
d-ROM, BAP, BS, HbA1c, GA, Inslin, Waist circumference, TG, HDL-Cholesterol, Blood Pressure, PHQ-9, SF-8, STAI, and metabolites, at 0, 4 and 8 weeks after test start
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Rice, 8 weeks
Interventions/Control_2
Grains except rice (however, this shall not be applied for dinner), 8 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged equal to or more than 40 years and less than 70 years
2. Healthy males and females without any treatment
3. Subjects who have high score in PSQI-J and have one or more of Metabolic syndrome diagnostic criteria
4. Subjects who regularly take 3 meals a day.
5. Subjects who usually take grains except rice at least 1 meal of 3 meals a day.
6. Subjects who understand the object and contents of the study and submit written informed consent
Key exclusion criteria
1. Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure
2. Subjects who are treated sleeplessness or sleep disorder
3. Subjects who plan to become pregnant, who are during pregnancy, or who are nursing
4. Subjects who participate in other clinical trials or whose participation finishes within one month prior to the current clinical trial
5. Subjects who have marked impairment of liver, kidney, heart
6. Subject with a history of allergy to medicine and food
7. Subjects who smoke excessively and drink alcohol habitually
8. Subjects whose eating habits are extremely irregular or who are midnight and irregular shift workers
9. Subjects who are ineligible due to physician's judgment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kusumi Ichiro |
Organization
Hokkaido Graduate School of Medicine
Division name
Department of Phychiatry
Zip code
Address
7tyoume, Kita15-jonishi, Kita-ku Sapporo-shi, Hokkaido, Japan
TEL
011-706-5160
ikusumi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Shimpei |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1, Toiso, Eniwa-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Hokkaido Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 22 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 22 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029579
