UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037620 |
|---|---|
| Receipt number | R000042891 |
| Scientific Title | A study on the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat. |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2020/02/05 15:27:35 |
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Basic information
Public title
A study on the effect of LAB (heat-killed) on Visceral Fat.
Acronym
A study on the effect of LAB (heat-killed) on Visceral Fat.
Scientific Title
A study on the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat.
Scientific Title:Acronym
A study on the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Abdominal subcutaneous fat area, total fat area, body weight (BMI), blood pressure, body fat percentage, muscle mass, waist/hip circumference, AST (GOT), ALT (GPT), gamma-GTP, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood glucose level, insulin, HbA1c, HOMA-IR, fecal microbiota.
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
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A beverage not containing heat-killed Labre per day for 12 weeks.
Interventions/Control_2
A beverage containing heat-killed Labre (low-dose) per day for 12 weeks.
Interventions/Control_3
A beverage containing heat-killed Labre (high-dose) per day for 12 weeks.
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)Japanese male and female aged 20 to 64 years-old at acquisition of the consent.
(2)Whose BMI are 23 or more and less than 30 at screening test.
(3)Who can make self-judgment, voluntarily agreed to participate to this study, and provide written informed consent.
Key exclusion criteria
(1)Who use medicines that may affect obesity, hyperlipidemia, lipid metabolism.
(2)Who has such serious diseases as liver disease, cardiovascular disease, respiratory disease, endocrine disorder, metabolic disease, food allergy disease.
(3)Who cannot stop intake health foods or supplements which may affect obesity, hyperlipidemia, lipid metabolism, during this study.
(4)Who has a current or history of drug dependence and/or alcoholism.
(5)Who has been implanted metal in the DUAL SCAN measurement site.
(6)Who has implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(7)Who has been diagnosed as familial hyperlipidemia.
(8)Who is pregnant or breast-feeding or willing to be pregnant during this study.
(9)Who has an irregular diet, and/or is shift worker and/or midnight-shift worker.
(10)Who is planning to participate and/or has participated in other clinical studies.
(11)Who is judged as unsuitable for this study by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
Kagome Co., Ltd.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0014
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.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
| 2019 | Year | 08 | Month | 24 | 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
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042891
