UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single arm pilot study to assess the effect of habitual Japan Diet intake on chronic inflammation in middle-aged Japanese men
Title of the study (Brief title)	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	Chizuko Maruyama
Organization	Japan Women's University
Division name	Department of Food and Nutrition, Faculty of Human Sciences and Design
Address	2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL	03-5981-3428
Email	maruyama@fc.jwu.ac.jp

Public contact
Name of contact person	Chizuko Maruyama
Organization	Japan Women's University
Division name	Department of Food and Nutrition, Faculty of Human Sciences and Design
Address	2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL	03-5981-3428
Homepage URL
Email	maruyama@fc.jwu.ac.jp

Sponsor
Institute	The Japan Diet Study Group of JWU
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023820