UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056967 |
|---|---|
| Receipt number | R000064996 |
| Scientific Title | Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices |
| Date of disclosure of the study information | 2025/02/09 |
| Last modified on | 2025/03/04 14:26:55 |
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Basic information
Public title
Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices
Acronym
Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices
Scientific Title
Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices
Scientific Title:Acronym
Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices
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 effects of Lactobacilli-containing foods on blood anti-aging indices after four weeks of consumption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-aging index
(Week 0, Week 4)
Key secondary outcomes
*Secondary indexes
1) Survey of subjective symptoms of aging (1)
*Safety
1) Physical examination (1)
2) Clinical examination (1)
3) Doctor's questions (1)
4) Existence and its contents of side effects (2)
5) Adverse events (2)
(1): Week 0, Week 4
(2): Week 4
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 the test food (1 packet per day; 4 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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 60 and 69 years of age at the time of obtaining consent to participate in the study.
2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
3) Individuals who can come to the designated venue for this study and be inspected.
4) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
1)using medical products.
2)with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
3) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
4) who are a patient or have a history of or endocrine disease.
5) who are taking medications for more than 2 days per week that may affect the study and cannot be restricted during the study period (intestinal medications, antibiotics)
6) with a BMI of 30 kg/m2 or greater.
7) with systolic blood pressure less than 90 mmHg.
8) who experienced unpleasant feeling during blood drawing.
9) with drug and food allergies.
10) who regularly use Food for Specified Health Use, Food with Functional Claims, etc.
11) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
12) who have a smoking habit, and individuals who have had a smoking habit within the past year.
13) Shift workers or night workers.
14) who may change their lifestyle during the study period (e.g., long trips).
15) who have donated component blood or 200 mL of whole blood in the month prior to the start of the study.
16) who donated 400 mL of whole blood 4 months prior to the start of the study.
17) whose blood volume collected in the 12 months prior to the start of the study plus the total planned blood volume for the study exceeds 800 mL.
18) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
19) judged inappropriate for the study by the principal.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Morifuji |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs 3G
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, JAPAN
TEL
042-632-5846
masashi.morifuji@meiji.com
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
Meiji Holdings 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
| 2025 | Year | 02 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064996
