UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032621
Receipt number R000037186
Scientific Title Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area.
Date of disclosure of the study information 2018/06/01
Last modified on 2018/12/17 10:36:17

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Basic information

Public title

Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area.

Acronym

Effects of lactic acid bacteria beverage on visceral fat area.

Scientific Title

Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area.

Scientific Title:Acronym

Effects of lactic acid bacteria beverage on visceral fat area.

Region

Japan


Condition

Condition

obesity

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of long-tern ingestion of lactic acid bacteria beverage on suppression of visceral fat area.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visceral fat area

Key secondary outcomes

Body weight,Body fat percentage,Waist length,Subjective symptoms


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects ingested the active meal for eight weeks.

Interventions/Control_2

The subjects ingested the placebo meal for eight weeks.

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

20 years-old <=

Age-upper limit

30 years-old >

Gender

Female

Key inclusion criteria

1) Aged more than 20 (Healthy female between 20 and 30 years old)
2) Individuals who can refrain from drinking and eating during the test period
3) Individuals who understand the purpose and contents of the experiment

Key exclusion criteria

1)Individuals taking drugs, supplements and healthy foods which affect the Lipid metabolism
2)Those who can not stop taking supplements or health foods that may affect Lipid metabolism during the test period
3)Subjects who are contracting kidney and/or liver diseases
4)Those who have been diagnosed with Familial hyperlipidemia
5)Individuals with a chronic diseases
6)Those who can not stop taking a large amount of lactic acid bacteria beverage other than the test food during the test period
8)Pregnant women, or women with intending to become pregnant, and lactating woman
8)Individuals participating or intending to participate in a drug administration test
9)Individuals judged by the doctor to be unsuitable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunari Tanaka

Organization

Univercity of Nagasaki

Division name

Faculty of Nursing and Nutrition

Zip code


Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

095-813-5216

Email

katanaka@sun.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Ito

Organization

Univercity of Nagasaki

Division name

Regional Collaboration Center

Zip code


Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

095-813-5500

Homepage URL


Email

katanaka@sun.ac.jp


Sponsor or person

Institute

Univercity of Nagasaki

Institute

Department

Personal name



Funding Source

Organization

Andotsusyo Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sojo Univercity

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



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 01 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

2018 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 17 Day

Last modified on

2018 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037186


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name