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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name