UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032621 |
|---|---|
| Receipt number | R000037186 |
| Scientific Title | Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/12/17 10:36:17 |
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Basic information
Public title
Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area.
Acronym
Effects of lactic acid bacteria beverage on visceral fat area.
Scientific Title
Study on effects of long-tern ingestion of lactic acid bacteria beverage on visceral fat area.
Scientific Title:Acronym
Effects of lactic acid bacteria beverage on visceral fat area.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of long-tern ingestion of lactic acid bacteria beverage on suppression of visceral fat area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
Key secondary outcomes
Body weight,Body fat percentage,Waist length,Subjective symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested the active meal for eight weeks.
Interventions/Control_2
The subjects ingested the placebo 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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
1) Aged more than 20 (Healthy female between 20 and 30 years old)
2) Individuals who can refrain from drinking and eating during the test period
3) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria
1)Individuals taking drugs, supplements and healthy foods which affect the 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 kidney and/or liver diseases
4)Those who have been diagnosed with Familial hyperlipidemia
5)Individuals with a chronic diseases
6)Those who can not stop taking a large amount of lactic acid bacteria beverage other than the test food during the test period
8)Pregnant women, or women with intending to become pregnant, and lactating woman
8)Individuals participating or intending to participate in a drug administration test
9)Individuals judged by the doctor to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanaka |
Organization
Univercity of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
095-813-5216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ito |
Organization
Univercity of Nagasaki
Division name
Regional Collaboration Center
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
095-813-5500
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Andotsusyo Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sojo Univercity
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 05 | Month | 17 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037186
