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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025723
Receipt No. 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

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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
Email 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
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute Hokkaido Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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