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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020372
Receipt No. 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

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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&#39;t stop drinking for 2 days before the days of screening and checkup.
2)Individuals who can&#39;t stop eating foods containing lactic acid bacteria and/or oligosaccharide, fermented foods during this study.
3)Individuals who can&#39;t stop eating functional foods which may affect immune functions.
4)Individuals who have a history of irritable bowel syndrome and Crohn&#39;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
Email 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
Email shimakaz@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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