UMIN-CTR Clinical Trial

Basic information
Public title	Association between dietary patterns and sleep quality, temperament, stress sensitivity & QOL in a general adult population - investigation in the population with/without metabolic syndrome
Acronym	Association between dietary patterns and sleep quality, temperament, stress sensitivity & QOL
Scientific Title	Association between dietary patterns and sleep quality, temperament, stress sensitivity & QOL in a general adult population - investigation in the population with/without metabolic syndrome
Scientific Title:Acronym	Association between dietary patterns and sleep quality, temperament, stress sensitivity & QOL
Region	Japan

Condition
Condition	Psychiatric disorders, sleep disorder
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the association between dietary patterns and physical and mental health in a general adult population.
Basic objectives2	Others
Basic objectives -Others	To clarify the association between diet and health by correlation analysis, covariance structure analysis and cluster analysis using data from the questionnaires.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Dietary patterns for the last one month by self-administered survey (nutrition and foods)
Key secondary outcomes	1. Health survey Global Physical Activity Questionnaire (GPAQ), Sleep quality (Pittsburgh Sleep Quality Index Japanese version, PSQI-J), Temperament (EPQ neuroticism short version and Temperament Evaluation of Memphis, Pisa, Paris and San Diego-auto questionnaire version, TEMPS-A), Impulsiveness (Barratt Impulsive Scale, BIS), Depressiveness (Patient Health Questionnaire, PHQ-9), Stress sensitivity (Life Experiences Survey, LES), and QOL (SF-8). Scores from these health indices for the analysis. 2. Statistics 2-1. Direct correlation between Nutrition & foods and health indices by Pearson's correlation test. 2-2. Indirect correlation between Nutrition & foods and health indices by covariance structure analysis. 2-3. Identifying subgroups according to dietary patterns by cluster analysis with k-means method, and comparison of the differences of health scores among the subgroups by ANOVA with Tukey-Kramer's adjustment.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Healthy adults
Key exclusion criteria	Undergoing medical treatment
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Minori Middle name Last name Koga
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code	060-8638
Address	Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
TEL	011-706-5160
Email	mkoga@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Minori Middle name Last name Koga
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code	060-8638
Address	Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
TEL	011-706-5160
Homepage URL
Email	mkoga@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Institutional Ethical Board for Epidemiological Studie
Address	Kita-15 Nishi-7 Kita-ward Sapporo Hokkaido, Japan
Tel	011-706-5003
Email	shomu@med.hokudai.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	14-059
Org. issuing International ID_1	The Institutional Ethical Board for Epidemiological Studies at Hokkaido University Graduate School of Medicine
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 02 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	278
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Delay for publication
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	Main results already published
Date of protocol fixation	2015 Year 01 Month 16 Day
Date of IRB	2015 Year 01 Month 30 Day
Anticipated trial start date	2015 Year 01 Month 17 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The result of the present study suggested weak association between dietary patterns and health by Pearson's correlation test and covariance structure analysis. Cluster analysis identified specific subgroups related to the improvement of physical and mental health.

Management information
Registered date	2016 Year 12 Month 30 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029158