UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063131 |
|---|---|
| Receipt number | R000072181 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/10/01 14:12:46 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition
Acronym
A Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition
Scientific Title:Acronym
A Study to Evaluate the Effects of Lactobacillus Fermentation Products Intake on Maintenance of Physical Condition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of continuous intake of the test food for 8 weeks on maintenance of physical condition and immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-reported cold-like symptoms
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
Participants will consume one packet of the test food daily for 8 weeks.
Interventions/Control_2
Participants will consume one packet of the placebo food daily for 8 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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals aged 35-65 at consent
2. Japanese men and women
3. BMI between 18.5 and 30.0 kg/m^2
4. Prone to catching colds
5. Go out at least once a week for work or social activities, with opportunities for contact with others
6. Experience fatigue in daily life
7. Able to enter electronic diaries via smartphone or PC
8. Fully informed about the study, capable of consent, and voluntarily agree in writing
Key exclusion criteria
1. Currently receiving treatment for any disease with medication or Kampo (as needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Have atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases
4. Diagnosed with dry mouth or Sjogren's syndrome, or aware of low salivary secretion
5. History or presence of serious diseases
6. Regularly consume lactic acid bacteria-containing foods, specified health foods, nutritional supplements, or functional foods claiming immune benefits (>=3 days/week) for over a month before screening; those consuming <=2 days/week may participate if intake stops after consent
7. Habitual excessive alcohol intake (>=40g pure alcohol/day)
8. Unable to abstain from alcohol from the day before each visit
9. Current smokers or those who quit less than 12 months ago
10. History of gastrointestinal diseases or surgeries affecting digestion/absorption (except endoscopic removal of colon polyps)
11. Ongoing oral or dental bleeding issues expected to persist during the study
12. Vaccinated or planning vaccination (e.g., influenza, COVID-19) within 1 month before screening or during the study
13. Known lactose intolerance or excessive abdominal symptoms after dairy intake
14. Current or past drug or food allergies
15. Rotating shift workers who work night shift
16. Plan to significantly change lifestyle (diet, sleep, exercise) during the study
17. Plan to travel abroad during the study
18. Pregnant, breastfeeding, or planning pregnancy during the study
19. Blood donation or blood draw of 200mL within 1 month or 400mL within 3 months before screening
20. Participation in other clinical or monitoring studies within 1 month before screening or plans to participate during the study
21. Deemed unsuitable by the principal investigator for any other reason
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Toshimitsu |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
042-632-5847
takayuki.toshimitsu@meiji.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072181
