UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046378 |
|---|---|
| Receipt number | R000052867 |
| Scientific Title | Effects of feeding high concentration of lactic acid bacterium producing substance PS-B1on visceral fat |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2022/12/13 12:28:29 |
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Basic information
Public title
Effects of feeding high concentration of lactic acid bacterium producing substance PS-B1on visceral fat
Acronym
Effects of feeding high concentration of lactic acid bacterium producing substance on visceral fat
Scientific Title
Effects of feeding high concentration of lactic acid bacterium producing substance PS-B1on visceral fat
Scientific Title:Acronym
Effects of feeding high concentration of lactic acid bacterium producing substance on visceral fat
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of high concentration of lactic acid bacterium producing substance on suppression of visceral fat
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Body height, Body weight, Body fat percentage, BMI, Waist length, Blood pressure, Serum cholesterol, HDL-C, LDL-C, Serum triglyceride, Blood glucose , AST, ALT, Gamma-GTP, White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, LDH, ALP, HbA1c, Total protein, Albumin, Creatinine, Uric acid, VAS method (fatigue and defecation feeling)
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested the placebo meal for eight weeks
Interventions/Control_2
The subjects ingested the active meal for eight 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male and female between 20 and 80 years old
2) Body mass index between 23 and 30
3) Individuals who can refrain from over drinking and over eating during the test period
4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria
1)Individuals taking drugs affect lipid metabolism
2)Those who can not stop taking supplements or health foods that may affect lipid metabolism during the test period
3)Subjects who are contracting or treating severe diabetes and kidney and/or liver diseases
4)Those who have been diagnosed to be dyslipidemia
5)Those who can not stop taking a large amount of lactic acid bacteria beverage during the test period
6)Pregnant women, or women with intending to become pregnant, and lactating woman
7)Individuals participating or intending to participate in other drug administration tests
8)Individuals judged by the doctor to be unsuitable
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ito |
Organization
Univercity of Nagasaki
Division name
Regional Partner Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Biogenomics Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel
0958135216
katanaka@sun.ac.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
| 2021 | Year | 12 | Month | 15 | 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
80
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
| 2021 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052867
