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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027709
Receipt No. 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

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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
Institute KSO Corporation
Institute
Department

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
URL(English) https://upload.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


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