UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057172 |
|---|---|
| Receipt number | R000065356 |
| Scientific Title | Exploratory Study on the Effects of Continuous Lactobacillus Intake on Frailty-Related Indicators in the Elderly - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial - |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2026/04/03 12:46:56 |
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Basic information
Public title
Exploratory Study on the Effects of Continuous Lactobacillus Intake on Frailty-Related Indicators in the Elderly
Acronym
Exploratory Study on the Effects of Continuous Lactobacillus Intake on Frailty-Related Indicators in the Elderly
Scientific Title
Exploratory Study on the Effects of Continuous Lactobacillus Intake on Frailty-Related Indicators in the Elderly
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial -
Scientific Title:Acronym
Exploratory Study on the Effects of Continuous Lactobacillus Intake on Frailty-Related Indicators in the Elderly
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 24 weeks of continuous intake of the test food on frailty-related indicators in healthy elderly male and female aged 60 years or older but less than 75 years, who are aware of declines in muscle strength or muscle mass.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Muscle mass
Key secondary outcomes
-Body composition (body weight, BMI, fat mass)
-Bone mineral density
-Physical performance (normal walking speed, Timed Up and Go [TUG] test, chair stand test, knee extension strength, handgrip strength)
-Inflammatory markers (IL-6, high-sensitivity CRP)
-Frailty criteria (based on the J-CHS criteria)
- Profile of Mood States (POMS2)
- MOS 36-Item Short-Form Health Survey (SF-36)
-Blood tests (hematology and biochemical tests)
-Physiological examinations (blood pressure, pulse rate)
-Incidence of adverse events and side effects
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 intake 1 g of powdered test food, 1 sachet, 1.0 g, with water once daily at any time for 24 weeks.
Interventions/Control_2
Participants will intake 1 g of powdered placebo food, 1 sachet, 1.0 g, with water once daily at any time for 24 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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 60 or older but less than 75 years.
2. Japanese male and female.
3. Aware of declines in muscle strength or muscle mass.
4. BMI of 18.5 kg/m^2 or greater but less than 25.0 kg/m^2.
5. Capable of entering data into an electronic diary using a smartphone or PC.
6. Provided written informed consent after receiving sufficient explanation regarding the study's purpose and content and voluntarily agreed to participate.
Key exclusion criteria
1. Current or past history of severe diseases.
2. Individuals under physician-supervised dietary or exercise therapy.
3. Have a musculoskeletal disorder affecting mobility including sarcopenia.
Sarcopenia is defined as meeting both of the following criteria:
-SMI < 7.0 kg/m^2 for men or < 5.7 kg/m^2 for women
-Handgrip strength < 28 kg for men, < 18 kg for women, or normal walking speed < 1 m/sec.
4. Regular use of medications or quasi-drugs (e.g., anti-diabetic drugs, laxatives, NSAIDs, steroids, or topical agents with anti-inflammatory effects) that may influence the study and inability to refrain from such use during the study except occasional use.
5. Habitual use of functional foods, health supplements, or dietary supplements targeting muscle strength or mass maintenance at least three times weekly. Habitual consumption of food products containing active study ingredients is also excluded unless discontinued from the time of consent through the study period.
6. History or current presence of drug or food allergies.
7. Excessive alcohol intake.
8. Excessive smoking habits.
9. Habitual engagement in strength training.
10. Shift workers with night shifts.
11. Anticipated significant changes in lifestyle including diet, sleep, or exercise during the study period.
12. Planned overseas travel during the study period.
13. Presence of implanted orthopedic metal devices.
14. Enrollment in another clinical trial within one month prior to obtaining consent, ongoing participation, or plans to participate in another trial during the study period.
15. Considered unsuitable for study participation by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
R&D division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5847
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
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,Shinjyuku,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
| 2025 | Year | 04 | Month | 04 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 21 | 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 | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065356
