UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022880 |
|---|---|
| Receipt number | R000026352 |
| Scientific Title | A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/06/26 09:09:59 |
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Basic information
Public title
A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial
Acronym
A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue
Scientific Title
A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of ingestion of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary sIgA secretion rate
Key secondary outcomes
salivary sIgA concentration, POMS2
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
Ingestion of test food containing a lactic acid bacterium for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo without a lactic acid bacterium for 12 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females from 20 to 64 years of age
2) Lower salivary secretory immunoglobulin A secretion rate
3) POMS2-AS FI T score : >= 50 and VA T score : <= 50
Key exclusion criteria
1) Subjects that regularly consume food rich in lactic acid bacteria more than 3 times a week
2) Subjects with regular consumption of lactic acid bacteria -fortified food or lactic acid bacteria preparation
3) Subjects that regularly consume dietary supplements which may influence immune function
4) Subjects with history of the allergic disease
5) Subjects undergoing medical treatment which may influence the outcome of the study (e.g., hyposensitization)
6) Subjects who have received oral or dental treatment from one month before the screening tests or intend to receive oral or dental care during the study
7) Subjects with oral or dental problems (e.g., stomatitis, oral mucosal bleeding) or develop them more than once a week
8) Subjects with regular bleeding gums during brushing
9) Night and day shift worker or manual laborer
10) Subjects with intensive physical activity (e.g., marathon race)
11) Subjects with poor adherence to the measurement procedures
12) Subjects undergoing medical treatment or require medical treatment
13) Subjects with severe diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) and diseases that may affect the adrenal cortical hormone secretion
14) Subjects potentially allergic to contents in test food such as lactic acid bacteria
15) Subjects who are judged inappropriate for the study according to the results of screening tests
16) Subjects who intend to become pregnant during the study period or being pregnant or lactating
17) Subjects who have participated in other clinical studies within one month from obtaining informed consent or intend to participate in other clinical studies after obtaining informed consent
18) Subjects who are judged inappropriate for the study according to the results of lifestyle questionnaire
19) Subjects who are judged inappropriate for the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Kouchi |
Organization
Kikkoman Corporation
Division name
Research and Development Division
Zip code
Address
399 Noda, Noda-shi, Chiba
TEL
04-7123-5554
tkouchi@mail.kikkoman.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Shimada |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
h.shimada@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kikkoman Corporation
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
| 2017 | Year | 04 | 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
| 2016 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 26 | 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
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026352
| 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 |
