UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025853
Receipt No. 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

* 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
Email 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
Email husu33@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University Nutrition Clinic
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.