UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027709
Receipt number R000031741
Scientific Title Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2017/06/12
Last modified on 2018/06/01 10:46:11

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Basic information

Public title

Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study

Acronym

Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria

Scientific Title

Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study

Scientific Title:Acronym

Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria

Region

Japan


Condition

Condition

Overweight

Classification by specialty

Medicine in general Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of reducing body fat by the intake of food containing lactic acid bacteria

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Abdominal total fat area
Abdominal visceral fat area
Abdominal subcutaneous fat area

Key secondary outcomes

Body weight
Body mass index
Body fat percentage
Waist circumference, Hip circumference, Waist circumference/hip circumference
Blood fat level (triglyceride, total cholesterol, HDL cholesterol, LDL cholesterol)
Blood glucose level
HbA1c
Insulin
HOMA-IR
Blood ketone bodies level
Blood inflammatory cytokines
Blood adiponectin


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of the test food

Interventions/Control_2

12-week intake of the placebo food

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Healthy men and women of 20 to 64 years age
2)Subjects whose body mass indexes were 25 to 30 at the screening period
3)Subjects giving written informed consent

Key exclusion criteria

1)Subjects with severe onset of obesity-related disease (impaired glucose tolerance, dyslipidemia, hypertension, hyperuricemia, coronary artery disease, cerebral infarction, fatty liver, menstrual disorder and pregnancy complications, sleep apnea syndrome or obesity hypoventilation syndrome, orthopedic surgery, obesity-related kidney disease)
2)Subjects with food allergy or lactose intolerance
3)Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test
4)Subjects with a habit of oral medication, supplements, health food affecting obesity, hyperlipidemia, glucese or lipid matabolism in three months before screening test, and subjects who will take these in the test period.
5)Subjects who are regularly practicing intense exercise (exercising for the purpose of muscle strengthening, attending exercise facilities more than three times in a week, etc.)
6)Subjects who have been drug dependency or alcohol dependency
7)Subjects who drink a lot of alcohol, and subjects who can not abstain from drinking from two days before the examination date
8)Subjects who have metal in the measurement site of CT scan
9)Subjects who contain cardiac pacemaker, implantable defibrillator
10)Subjects who have been diagnosed with familial hyperlipemia
11)Subjects in pregnancy or in nursing
12)Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker)
13)Subjects who participated in other clinical trials within one month before the agreement of participants in this study
14)Subjects with claustrophobia
15)Subjects who are judged as unsuitable for the study by the investigator for other reasons

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoru Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical examination and treatment management family chief director

Zip code


Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

TEL

81-3-3452-3381

Email

satoru_suzuki@sempos.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code


Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka buildin

TEL

81-3-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Food Microbiology Research Laboratories, Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 12 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

2017 Year 06 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 25 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 01 Month 31 Day

Date trial data considered complete

2018 Year 02 Month 28 Day

Date analysis concluded

2018 Year 03 Month 28 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 09 Day

Last modified on

2018 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name