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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023919
Receipt No. R000027542
Scientific Title A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.
Date of disclosure of the study information 2016/09/02
Last modified on 2017/08/28

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Basic information
Public title A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.
Acronym A study to assess the effect of Bifidobacteria ingestion on visceral fat reduction.
Scientific Title A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.
Scientific Title:Acronym A study to assess the effect of Bifidobacteria ingestion on visceral fat reduction.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of Bifidobacteria ingestion on reducing visceral fat in overweight adult.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes abdominal visceral fat area (Time frame: 12 weeks)
Key secondary outcomes Body composition (body weight, body fat mass, body fat percentage, BMI, visceral fat area, subcutaneous fat area, total fat area), Waist circumference, Serum lipids (Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides), Diabetes associated markers (fasting plasma glucose, HbA1c, glycoalbumin, fasting serum insulin), liver function (AST, ALT, gamma-GTP, ALP), inflammatory marker (hs-CRP, LBP), enteric environment (enterobacterial flora analysis, defecation frequency)

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of probiotics (Bifidobacteria) for 12 weeks.
Interventions/Control_2 Ingestion of placebo for 12 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
65 years-old >
Gender Male and Female
Key inclusion criteria Subjects who have BMI ranging from 25 to <30.
Key exclusion criteria (1) Subjects who have history or receiving treatment of serious disease
(2) Subject with gastrointestinal related disease and undertake medication
(3) Subject who is under medication for diabetes, hypertension or dyslipidemia
(4) Subject with a history of serious allergy to medicine and food
(5) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
(6) Heavy smoker and heavy drinker, or subject with irregular lifestyle
(7) Subject who is ineligible due to physician's judgment based on background of subject, physical finding, interview
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Suzuki, M.D.
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical Examination and Treatment Management Family
Zip code
Address 1-2-70 Konan, Minato-ku, Tokyo, 108-0075, Japan
TEL 03-3452-3381
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 President-director
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo, 105-0023, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Hospital Organization Kyoto Medical Center
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 品川シーズンテラス健診クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 02 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 08 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 09 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
2016 Year 09 Month 02 Day
Last modified on
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027542

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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