UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048757 |
|---|---|
| Receipt number | R000054860 |
| Scientific Title | Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function indicates |
| Date of disclosure of the study information | 2022/08/29 |
| Last modified on | 2024/03/18 14:51:06 |
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Basic information
Public title
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function indicates
Acronym
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function indicates
Scientific Title
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function indicates
Scientific Title:Acronym
Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function indicates
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 8 and Week 12)
Key secondary outcomes
*Secondary outcomes
[1] AST (1)
[2] Gamma -GT (1)
[3] Specific blood test (1)
[4] 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] Subject's diary (2)
[7] Doctor's questions (1)
[8] Adverse events: number of cases and expression rate of adverse events (3)
(1): Week 0, Week 8 and Week 12
(2): From the first day of intake of test food to the last day of the test.
(3): Week 8, Week 12
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test food (Once a day; 12 weeks).
Interventions/Control_2
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 and Female
Key inclusion criteria
[1] Males and postmenopausal females 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] Selected mainly for those with elevated values of liver function-related indicators.
[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 regularly use vitamins.
[3] Individuals who used or applied a drug for treatment of disease in the past 1 month.
[4] Individuals who have, are undergoing treatment, or have a history of serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases.
[5] Individuals who contract or have a history of serious endocrine disease.
[6] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[7] Individuals who experienced unpleasant feeling during blood drawing.
[8] Individuals who are sensitive to test product or other foods, and medical products (especially allergies to wheat).
[9] Individuals with serious anemia.
[10] Individuals with bleeding teeth or oral problems, such as periodontal disease or mouth ulcer.
[11] Individuals who have significant changes in their physical condition due to menopause.
[12] Individuals who regularly use food for specified health use, functional foods, and health foods.
[13] Individuals who regularly use foods or supplements containing lactic asid bacteria and bifidobacterium.
[14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[15] Individuals who are smoker.
[16] Individuals with possible changes of life style during the test period.
[17] Individuals who habitually perform strenuous exercise such as running, marathon, soccer, etc.
[18] Individuals who participated in other clinical studies in the past a month.
[19] Individuals who are judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Takeo |
Organization
Takeo Clinic.
Division name
Head
Zip code
154-0004
Address
3F Morisumi Building, 4-22-7 Taishido, Setagaya-ku, Tokyo 154-0004, JAPAN
TEL
+81-3-5433-3255
h.takeo@step-networks.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
103-0023
Address
516 Nihonbashinagatani Bldg, 3-1-6 Nihonbashihoncho, Chuo-ku, Tokyo 103-0023, JAPAN
TEL
+81-80-4163-4418
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
CXwellness, Inc.
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
+81528382485
i.takahashi@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
| 2022 | Year | 08 | Month | 29 | 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
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054860
