UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018410 |
|---|---|
| Receipt number | R000021316 |
| Scientific Title | Test of the energy metabolism-promoting effect of lactic acid bacteria beverage |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2016/07/20 14:21:59 |
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Basic information
Public title
Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Acronym
Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Scientific Title
Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Scientific Title:Acronym
Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the energy metabolism-promoting efficacy and safety of lactic acid bacteria beverage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
energy metabolism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
lactic acid bacteria beverage
Interventions/Control_2
lactic acid bacteria-free beverage
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
1) Males and females aged 20 to less than 65 years old.
2) 25 kg/m2 <= BMI < 30 kg/m2.
Key exclusion criteria
1) Subjects who regularly take part in exercise and/or sports (except taking a walk) or do muscle training three times and more a week.
2) Subjects who are on a diet.
3) Subjects who have the habit of taking foods containing a high number of lactic acid bacteria (fermented milk drink, yoghurt, kimuchi, and so on) and/or lactic acid bacteria preparations three times and more a week.
4) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the body fat and/or fat metabolism, or who constantly use medicines and/or functional foods affecting the test results.
5) Subjects who take continuous medical treatment.
6) Subjects who have allergic reaction to food.
7) Subjects who drink alcohol a lot (20 g and more of alcohol a day on average) and/or smoke a lot (21 and more cigarettes a day on average)
8) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
9) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Nakamura |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0460
Junichi_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Fukushima |
Organization
Suntory Global Innovation Center Limited
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0544
Homepage URL
Eiji_Fukushima@suntory.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
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
| 2015 | Year | 07 | Month | 27 | 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
| 2015 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | 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
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
