UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025853 |
|---|---|
| Receipt number | R000029729 |
| Scientific Title | Establishment of eating habits aimed at prevention of life-style related diseases : consider usability of mastication by salad vegetable before dinner |
| Date of disclosure of the study information | 2017/01/26 |
| Last modified on | 2017/07/27 09:10:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishment of eating habits aimed at prevention of life-style related diseases : consider usability of mastication by salad vegetable before dinner
Acronym
Influence of mastication by salad vegetable before dinner on visceral fat.
Scientific Title
Establishment of eating habits aimed at prevention of life-style related diseases : consider usability of mastication by salad vegetable before dinner
Scientific Title:Acronym
Influence of mastication by salad vegetable before dinner on visceral fat.
Region
| Japan |
Condition
Condition
healthy adults (BMI>=18.0kg/m2)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effects of mastication by salad vegetable for 10 minutes before dinner on the reduction of visceral fat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Body weight, BMI, Abdominal circumference, Percent body fat,Blood pressure,Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglyceride, Blood glucose, Insulin, 1.5AG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom | Maneuver |
Interventions/Control_1
1. To eat assigned meals ( 3 times per day ), and to drink by vegetable juice before dinner 3days (non-mastication period).
2. A wash out period (over a 1-week period)
3. To eat assigned meals ( 3 times per day ), and to mastication by salad vegetable before dinner 3days (mastication period).
Interventions/Control_2
1. To eat assigned meals ( 3 times per day ), and to mastication by salad vegetable before dinner 3days (mastication period).
2. A wash out period (over a 1-week period)
3. To eat assigned meals ( 3 times per day ), and to drink by vegetable juice before dinner 3days (non-mastication period).
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
| Not applicable |
Gender
Male
Key inclusion criteria
Abdominal circumference>=85
Subjects who sign an informed consent form to participate in the study.
Key exclusion criteria
1. Subjects who having difficulty in mastication.
2. Contraindication of MRI exam. (Subjects who have a heart pacemaker, metallic foreign body, metallic devices.)
3. Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
4. Subjects routinely on supplementation which would affect the visceral fat.
5. Any others judged ineligible as a subject by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Ueno |
Organization
Nakamura Gakuen University
Division name
Nutrition Clinic
Zip code
Address
5-7-1, Befu, Jounan-ku, Fukuoka city, Fukuoka
TEL
092-851-2869
husu33@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Ueno |
Organization
Nakamura Gakuen University
Division name
Nutrition Clinic
Zip code
Address
5-7-1, Befu, Jounan-ku, Fukuoka city, Fukuoka
TEL
092-851-2869
Homepage URL
husu33@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University Nutrition Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
中村学園大学栄養クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 26 | 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
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029729
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
