UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051994 |
|---|---|
| Receipt number | R000059258 |
| Scientific Title | Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function. |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2024/02/22 15:23:42 |
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Basic information
Public title
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function.
Acronym
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function.
Scientific Title
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function.
Scientific Title:Acronym
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of intake of test food on liver function indicates.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALT(Week 0, Week 6 and Week 12)
Key secondary outcomes
*Secondary outcomes
[1] AST (1)
[2] Gamma -GT (1)
[3] Brief-type self-administered diet history questionnaire (1)
*Safety
[1] Blood pressure, pulsation (1)
[2] Weight, body fat percentage, BMI (1)
[3] Hematologic test (1)
[4] Blood biochemical test (1)
[5] Urine analysis (1)
[6] Doctor's questions (1)
[7] Adverse events: number of cases and expression rate of adverse events (2)
[8] Subject's diary (3)
(1): Week 0, Week 6 and Week 12
(2): Week 6, Week 12
(3): From the first day of ingestion of a test material to the last day of the test.
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
Oral intake of test food (Once a day; 12 weeks).
Interventions/Control_2
Oral intake of placebo food (Once a day; 12 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
[1] Males aged 40-65 years, at the time of obtaining consent to participate in this study.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals with higher liver function-related indexes.
[4] Individuals whose BMI is more than 23.0 kg/m2 and less than 30.0 Kg/m2.
[5] Individuals whose written informed consent has been obtained after explanation of this study.
[6] Individuals who can have an examination on a designated check day.
[7] Individuals who are judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals who are currently receiving drug treatment due to some kind of illness. In addition, individuals who regularly use drugs or quasi-drugs for purposes other than disease treatment.
[2] Individuals who used or applied a drug for treatment of disease in the past 1 month.
[3] Individuals who have, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases.
[4] Individuals who contract or have a history of serious endocrine disease.
[5] Individuals with serious anemia.
[6] Individuals with bleeding teeth or oral problems, such as periodontal disease or mouth ulcer.
[7] Individuals who may have allergic symptoms to test product or wheat, other foods, and medical products.
[8] Individuals who regularly use food for specified health use, functional foods, and health foods.
[9] Individuals who regularly use foods and supplements containing vitamins, lactic acid bacteria and bifidobacteria
[10] Individuals who regularly drink alcohol (excessive alcohol drinkers).
[11] Individuals who are smoker. (including electronic cigarettes)
[12] Individuals with possible changes of lifestyle during the test period.
[13] Individuals who have habits to do high-intensity exercises such as running, marathon, or soccer.
[14] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[15] Individuals who participated in other clinical studies in the past 1 month.
[16] Individuals who are judged inappropriate for the study by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 24 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059258
