UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The pilot study for the effects of mastication by salad vegetable before dinner on the reduction of visceral fat.
Title of the study (Brief title)	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	Hiromi Ueno
Organization	Nakamura Gakuen University
Division name	Nutrition Clinic
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	Hiromi Ueno
Organization	Nakamura Gakuen University
Division name	Nutrition Clinic
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024263