UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041392 |
|---|---|
| Receipt number | R000047251 |
| Scientific Title | Effects of Lactic Acid Bacteria on Stress Response during an Arithmetic Task: An Exploratory Study. |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2021/09/21 09:32:42 |
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Basic information
Public title
Effects of Lactic Acid Bacteria on Stress Response during an Arithmetic Task: An Exploratory Study.
Acronym
Effects of Lactic Acid Bacteria on Stress Response during an Arithmetic Task: An Exploratory Study.
Scientific Title
Effects of Lactic Acid Bacteria on Stress Response during an Arithmetic Task: An Exploratory Study.
Scientific Title:Acronym
Effects of Lactic Acid Bacteria on Stress Response during an Arithmetic Task: An Exploratory Study.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lactic acid bacteria intake on healthy women during an arithmetic task.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Subjective symptoms of mood state before and after arithmetic task (shortened version of POMS 2 questionnaires, VAS, PMS, PATS and other subjective symptoms scores)
-Safety (adverse events and side effects)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of sachet containing lactic acid bacteria for 5 weeks
Interventions/Control_2
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
Female
Key inclusion criteria
1) Women aged 20 years or older and younger than 65 years.
2) Shortened version of POMS 2 FI (fatigue-Inertia) score is less than 50 in the first and second screenings.
Key exclusion criteria
1) Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and related severe past medical histories.
2) Subject who regularly takes foods containing lactic acid bacteria or bifidobacteria such as supplements, excluding yogurt.
3) Subject who regularly takes medicines and supplements that affect mood and fatigue.
4) Subject with drug allergies or severe food allergies and whom with related past medical histories.
5) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study.
6) Subject who has participated in other drug or food clinical trials within the past month.
7) Subject who is judged inappropriate to this trial based on the subject background, physical examination, etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Abe |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Food Ingredients & Technology Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref.
TEL
046-252-3036
f_abe@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Mutoh |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Probiotics research group, Food Ingredients & Technology Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref.
TEL
046-252-3036
Homepage URL
natsumi-mutou491@morinagamilk.co.jp
Sponsor or person
Institute
Morinaga Milk Industry 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo
Tel
03-6868-7022
jccr-info@jccr.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
| 2020 | Year | 08 | Month | 17 | 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
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 11 | 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
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047251
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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