UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of chewing and histidine intake for prevention and improvement of metabolic syndrome
Title of the study (Brief title)	Chewing and histidine intake
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of chewing and histidine intake for improvement of obesity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anthropometry (Height, Weight, Body fat percentage)
Key secondary outcomes	Blood pressure, Food intake, Blood (Glucose, Hemoglobin A1c, Triacylglycerol, Free fatty acid, T-Chol, HDL-Chol, LDL-Chol, Insulin, cortisol, AST, ALT, gamma-GTP)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	Control
Interventions/Control_2	Thirty -times chewing per bite ( for 12 weeks)
Interventions/Control_3	Intake of histidine 1g/day ( for 12 weeks)
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	18 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	Obtained written informed consent from the men before the participation
Key exclusion criteria	Those who felt this study was inconvenient to everyday life
Target sample size	30

Research contact person
Name of lead principal investigator	Toshiko Kuwano
Organization	The university of shizuoka
Division name	School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL	054-264-5513
Email	kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Toshiko Kuwano
Organization	The university of shizuoka
Division name	School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL	054-264-5513
Homepage URL
Email	kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute	The university of shizuoka
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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	2017 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 08 Month 28 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 29 Day
Last modified on	2017 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033551