UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025479 |
|---|---|
| Receipt number | 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 | 2021/01/05 09:02:54 |
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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
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
mkoga@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029158
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
