UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021028 |
|---|---|
| Receipt number | R000024263 |
| Scientific Title | The pilot study for the effects of mastication by salad vegetable before dinner on the reduction of visceral fat. |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2016/08/02 16:57:06 |
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Basic information
Public title
The pilot study for the effects of mastication by salad vegetable before dinner on the reduction of visceral fat.
Acronym
Influence of mastication by salad vegetable on visceral fat.
Scientific Title
The pilot study for the effects of mastication by salad vegetable before dinner on the reduction of visceral fat.
Scientific Title:Acronym
Influence of mastication by salad vegetable on visceral fat.
Region
| Japan |
Condition
Condition
healthy adults (BMI>=18)
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
The change of visceral fat at 4 weeks after the beginning of intervention and at 4 weeks after the end of intervention.
Key secondary outcomes
The change of body weight, BMI, abdominal circumference, percent body fat, blood pressure, T-Chol, HDL-C, LDL-C, TG, BS, IRI, HbA1c, AST, ALT, gamma-GTP, UA, adiponectin at 4 weeks after the beginning of intervention and at 4 weeks after the end of intervention.
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
Treatment
Type of intervention
| Food | Behavior,custom | Maneuver |
Interventions/Control_1
To continue mastication by salad vegetable for 10 minutes before dinner for 4 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | > |
Gender
Female
Key inclusion criteria
BMI>=18
Subjects who are not taking medicine.
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, Subjects who are pregnant or under lactation, or ones who have a possibility of becoming pregnant.
4, Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
5, Subjects routinely on supplementation which would affect the visceral fat.
6, Any others judged ineligible as a subject by the investigator.
Target sample size
3
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
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 02 | Month | 15 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 13 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 13 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024263
