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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025479
Receipt No. R000029158
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
Date of disclosure of the study information 2017/01/02
Last modified on 2019/07/20

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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 No longer recruiting
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
2019 Year 07 Month 20 Day


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

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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