UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the improvement effect of the sleep and the mental function with Japanese-style diet
Title of the study (Brief title)	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	Kusumi Ichiro
Organization	Hokkaido Graduate School of Medicine
Division name	Department of Phychiatry
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	Tomita Shimpei
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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