UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058977 |
|---|---|
| Receipt number | R000067448 |
| Scientific Title | Pilot study on the effects of lactic acid bacteria in young individuals |
| Date of disclosure of the study information | 2025/09/03 |
| Last modified on | 2025/09/03 10:47:51 |
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Basic information
Public title
Pilot study on the effects of lactic acid bacteria in young individuals
Acronym
Pilot study on the effects of lactic acid bacteria in young individuals
Scientific Title
Pilot study on the effects of lactic acid bacteria in young individuals
Scientific Title:Acronym
Pilot study on the effects of lactic acid bacteria in young individuals
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate amino acids absorption following the ingestion of protein combined with test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood amino acids ( total amino acids, essential amino acids, branched-chain amino acids)
Key secondary outcomes
Blood amino acid profile, Total Protein, Albumin, Total cholesterol, Hemoglobin
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Consecutive intake of test food and protein once a day for 15 days
Interventions/Control_2
Consecutive intake of placebo food and protein once a day for 15 days
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females from 18 to 29 years of age
2. Subjects whose BMI is less than 20 kg/m2
3. Subjects who defecate more than 3 times a week without laxative
4. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1. Subjects who have a positive or false positive result in any infectious disease test or who are carriers
2. Subjects who have any food allergies
3. Subjects who may develop allergies in relation to the study
4. Subjects who are taking healthy foods
5. Subjects who are prescribed medicines containing enzymes that enhance protein digestion and absorption, or gastric acid secretion regulators
6. Subjects who are prescribed laxatives or medicines or quasi-drugs that affect the intestinal flora
7. Subjects who regularly consume probiotic or prebiotic foods and beverages as part of their daily diet
8. Subjects who regularly consume foods or supplements that claim to contain enzymes supporting protein digestion, including digestive enzyme supplements
9. Subjects who are currently undergoing treatment or who have a disease that requires treatment
10. Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function
11. Subjects who have a disease requiring regular medication, including seasonal medication, during the study period, or those with a history of serious illness that required medication
12. Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
13. Subjects who have an irregular lifestyle, such as shift work or late-night work, and are unable to sleep the night before the test
14. Subjects who are participating in the other study within one month before the start of this study
15. Subjects who plan to travel or go on business trips abroad, long-term domestic travel or business trips, or frequent domestic business trips or domestic travel
16. Subjects who plan to become pregnant or breastfeed during the study period
17. Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
18. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiichiro |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Department, Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8969
eiichiro-naito@yakult.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
Development Department
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo, Japan
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
メディカルステーションクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 03 | 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
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067448
