UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029356 |
|---|---|
| Receipt number | R000033551 |
| Scientific Title | Effect of chewing and histidine intake for prevention and improvement of metabolic syndrome |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2017/09/29 19:27:41 |
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Basic information
Public title
Effect of chewing and histidine intake for prevention and improvement of metabolic syndrome
Acronym
Chewing and histidine intake
Scientific Title
Effect of chewing and histidine intake for prevention and improvement of metabolic syndrome
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshiko Kuwano |
Organization
The university of shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL
054-264-5513
kuwano@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiko Kuwano |
Organization
The university of shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-Ward, Shizuoka-City 422-8526, Japan
TEL
054-264-5513
Homepage URL
kuwano@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The university of shizuoka
Institute
Department
Personal name
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)
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
| 2017 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033551
