UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014138 |
|---|---|
| Receipt number | R000016080 |
| Scientific Title | Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt |
| Date of disclosure of the study information | 2014/06/02 |
| Last modified on | 2015/10/06 09:03:54 |
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Basic information
Public title
Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt
Acronym
Effects of Lactobacillus plantarum HOKKAIDO on immune functions
Scientific Title
Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt
Scientific Title:Acronym
Effects of Lactobacillus plantarum HOKKAIDO on immune functions
Region
| Japan |
Condition
Condition
Low immune system
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate effects of fermented milk (yogurt) containing Lactobacillus plantarum HOKKAIDO for activation of immune functions by double-blind, placebo-controlled test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
NK cell activity
Key secondary outcomes
Five fraction of leukocyte, IgG, IgE, IgM, IL-1, IL-4, IL-6, IL-8, IL-10, IL-12, T-Cho, LDL-Cho, HDL-Cho, TG, FBG, HbA1c, 25-OHD, MIF
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 90 g of yogurt containing Lactobacillus plantarum HOKKAIDO daily for 8 weeks.
Interventions/Control_2
Intake 90 g of yogurt daily for 8 weeks.
Interventions/Control_3
Intake 90 g of yogurt-like non-fermented products daily for 8 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects who show relatively low NK cell
activity
2.Subjects who agree to participate in the
current study with written informed
consent
Key exclusion criteria
1. Subjects who are under medication for chronic ailments.
2. Subjects with serious diseases and/or infections.
3. Subjects with clinical history of major gastrointestinal surgery.
4. Subjects with frequent complaints and/or symptoms relevant to post-menopausal events.
5. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
6. Subjects with serious anemia.
7. Subjects with a history of allergy to medicine and/or food, especially dairy products.
8. Subjects regularly on supplementation which would affect the immune system.
9. Subjects who often intake Hokkaido-strain containing products
10. Heavy smokers and alcohol addicts, or subjects with extremely irregular lifestyle.
11.Subjects who donated 400ml whole blood within 12 weeks or who donated plasma or platelets within 4 weeks prior to initiation of the current study.
12. Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the current study.
13. Subjects who participate in other clinical trials within the last one month prior to the current study.
14. Subjects who are not eligible due to physician's judgment
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido small business support center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1. Hokkaido milk products Co. Ltd.
2. Division of Laboratory and Transfusion Medicine, Hokkaido University Hospital
3. Roche Diagnostics K.K.
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
北海道情報大学 保健センター(北海道)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S2225411015000796
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
| 2014 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 27 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016080
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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