UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023919 |
|---|---|
| Receipt number | 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 14:46:57 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027542
