UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056115 |
|---|---|
| Receipt number | R000064076 |
| Scientific Title | Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition: Randomized, Double-blind, Placebo-controlled, Parallel Group Study |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/06 16:17:40 |
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Basic information
Public title
Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition
Acronym
Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition
Scientific Title
Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition: Randomized, Double-blind, Placebo-controlled, Parallel Group Study
Scientific Title:Acronym
Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 4 weeks ingestion of Lactobacillus material on the maintenance of physical condition in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition questionnaire
Key secondary outcomes
Immune function, QOL-related 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
Consume test food once a day for 4 weeks.
Interventions/Control_2
Consume placebo food once a day for 4 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who agree to participate in this study with a written informed consent.
2.Healthy Japanese males and females between 35 and 59 years old at the time of the screening test.
3.Those prone to catching colds.
Key exclusion criteria
1.Those with chronic diseases and use drug regularly.
2.Those have/ had diabetes, autoimmune disease, thyroid disease, adrenal disease.
3.Those with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring official reports.
4.Those with major surgical history related to the digestive system.
5.Those with seriously abnormal blood pressure, physical data or hematologic data.
6.Pregnant or lactating women or those planning to become pregnant.
7.Those who may have allergic reactions to drugs, foods or plants (esp. milk).
8.Those prone to diarrhea from dairy products.
9.Those who experienced discomfort during blood draw.
10.Those undergoing dental treatment or have dental/ oral issues involving bleeding at the time of the screening test, and whose symptoms are expected to continue throughout the study.
11.Pre- or post-menopausal women with obvious physical changes.
12.Those at risk of allergic reactions during the study.
13.Those who regularly taking health foods that affect this study at least 4 days per wk during the month prior to the screening test.
14.Those who regularly taking supplements at least 6 days per wk during the month prior to the screening test.
15.Those unable to stop taking foods claiming to maintain physical condition or immune function, yogurt, health foods, or supplements during the study.
16.Those have smoked within the past six mos.
17.Alcohol addicts.
18.Those with disordered lifestyle
19.Those planning to vaccination between the screening test and the final test.
20.Those planning to go abroad during the study.
21.Those who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks (both), or blood components within 2 wks (both), prior to the study.
22.Those participating or wish to participate in other clinical studies between 4 wks prior to the screening test and the final test.
23.Those ineligible due to physician's judgment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.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
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
| 2024 | Year | 11 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064076
