UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020639 |
|---|---|
| Receipt number | R000023820 |
| Scientific Title | A single arm pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men |
| Date of disclosure of the study information | 2016/01/19 |
| Last modified on | 2016/09/27 19:38:53 |
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Basic information
Public title
A single arm pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men
Acronym
A pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men
Scientific Title
A single arm pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men
Scientific Title:Acronym
A pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men
Region
| Japan |
Condition
Condition
Obesity, Metabolic syndrome
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a design of a randomized controlled-trial on the effect of the Japan Diet intake on chronic inflammation, the effects of increased intake of the Japan Diet foods on serum inflammation markers are assessed.
Basic objectives2
Others
Basic objectives -Others
To assess the effects of increased intake of the Japan Diet foods on glycemic and lipid parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relations between changes in the Japan Diet foods intake and serum oxidized-LDL concentration after 6 weeks intervention are assessed.
Key secondary outcomes
high-sensitive C-reactive protein
MCP-1
IL-6
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants attend one hour group education class concerning the health-related information and easy way to consume the foods classified to the Japan Diet. They are encouraged to keep a daily record of their body weight and performance on the targeted food intake for 6 weeks. The record is required to e-mail to the educator, and they receive supportive individual advice after 2 and 4 weeks by e-mail.
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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | > |
Gender
Male
Key inclusion criteria
Participants
-BMI>22
-free from any disease with medical treatment at screening
Key exclusion criteria
- Smoker
- Lipid-soluble vitamin supplement user
- Health food user
- Participants whose dietary habit should be dramatically changed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chizuko Maruyama |
Organization
Japan Women's University
Division name
Department of Food and Nutrition, Faculty of Human Sciences and Design
Zip code
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
03-5981-3428
maruyama@fc.jwu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chizuko Maruyama |
Organization
Japan Women's University
Division name
Department of Food and Nutrition, Faculty of Human Sciences and Design
Zip code
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
03-5981-3428
Homepage URL
maruyama@fc.jwu.ac.jp
Sponsor or person
Institute
The Japan Diet Study Group of JWU
Institute
Department
Personal name
Funding Source
Organization
Japan Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
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 | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2016 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023820
