UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039160
Receipt number R000044230
Scientific Title Study on effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on body fat.
Date of disclosure of the study information 2020/01/20
Last modified on 2020/07/15 15:28:18

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Basic information

Public title

Study on effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on body fat.

Acronym

Effects of beverages containing lactic acid bacterium producing substance on body fat.

Scientific Title

Study on effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on body fat.

Scientific Title:Acronym

Effects of beverages containing lactic acid bacterium producing substance on body fat.

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 beverages containing lactic acid bacterium producing substance on suppression of body fat.

Basic objectives2

Safety,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, BMI, Waist length, Blood pressure, Serum cholesterol, Serum triglyceride, Blood glucose level, GOT, GPT, Gamma-GTP, White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, LD, Total bilirubin, ALP, HbA1c, Total protein, Albumin, Urea nitrogen, Creatinine, Uric acid


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 placebo meal for eight weeks

Interventions/Control_2

The subjects ingested the active 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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Healthy male and female between 20 and 80 years old
2) Visceral fat area 80 cm2 or more, body mass index between 23 and 30
3) Individuals who can refrain from over drinking and over eating during the test period
4) Individuals who understand the purpose and contents of the experiment

Key exclusion criteria

1)Individuals taking drugs affect 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 or treating severe diabetes and 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 during the test period
7)Pregnant women, or women with intending to become pregnant, and lactating woman
8)Individuals participating or intending to participate in other drug administration tests
9)Individuals judged by the doctor to be unsuitable

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kaunari
Middle name
Last name Tanaka

Organization

Univercity of Nagasaki

Division name

Faculty of Nursing and Nutrition

Zip code

851-2195

Address

1-1-1 Manabino, Nagayo-cho, Nishisosnogi-gun, Nagasaki, Japan,

TEL

0958135216

Email

katanaka@sun.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Ito

Organization

Univercity of Nagasaki

Division name

Regional Partnership Center

Zip code

851-2195

Address

1-1-1 Manabino, Nagayo-cho, Nishisosnogi-gun, Nagasaki, Japan

TEL

0958135216

Homepage URL


Email

katanaka@sun.ac.jp


Sponsor or person

Institute

Univercity of Nagasaki

Institute

Department

Personal name



Funding Source

Organization

Biogenomics Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Univercity of Nagasaki

Address

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

Tel

0958135216

Email

katanaka@sun.ac.jp


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

2020 Year 01 Month 20 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

50

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

2019 Year 12 Month 14 Day

Date of IRB

2019 Year 11 Month 30 Day

Anticipated trial start date

2020 Year 01 Month 11 Day

Last follow-up date

2020 Year 03 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 15 Day

Last modified on

2020 Year 07 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name