UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020372 |
|---|---|
| Receipt number | R000023530 |
| Scientific Title | A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise. A randomized, double-blind, placebo- controlled trial. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/27 15:48:00 |
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Basic information
Public title
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise. A randomized, double-blind, placebo- controlled trial.
Acronym
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise.
Scientific Title
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise. A randomized, double-blind, placebo- controlled trial.
Scientific Title:Acronym
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function after exercise.
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of oral administration of lactic acid bacteria on immune functions after exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of dendritic cells and the immune-reaction of peripheral blood mononuclear cells to the stimulation of inactivated viruses (interferon-alpha production, and anti-viral genes expression), conditioning questionnaire.
Key secondary outcomes
Immune activity, stress hormone amount, and cytokine amount of blood, salivary immune activity and stress hormone amount, conditioning questionnaire.
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
Lactic acid bacteria, 1 portion of food per day for 13 days.
Interventions/Control_2
Placebo (not containing lactic acid bacteria), 1 portion of food per day for 13 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Males and females aged more than 20 years old, when giving the informed consent.
2)Individuals who have daily exercise.
3)Individuals who are received enough explanation of the purpose and the details of this study, who are decided to attend this study with their own will, who have ability of agreement, and who submit the informed consents in writing.
Key exclusion criteria
1)Individuals who can't stop drinking for 2 days before the days of screening and checkup.
2)Individuals who can't stop eating foods containing lactic acid bacteria and/or oligosaccharide, fermented foods during this study.
3)Individuals who can't stop eating functional foods which may affect immune functions.
4)Individuals who have a history of irritable bowel syndrome and Crohn's disease.
5) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
6)Individuals who have chronic diseases and use medicines continuously.
7)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
8)Individuals who are judged as unsuitable for this study based on the results of blood test.
9)Individuals with excessive alcohol-drinking behaviors.
10)Individuals who have a medical history of diseases affecting digestion and absorption.
11)Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
12)Individuals who are participating or willing to participate in other clinical trials.
13)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods.
14)Individuals with steroid treatment.
15)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody.
16)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
daida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, 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
順天堂大学大学院医学研究科／Juntendo University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | 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 | 12 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023530
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