UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058314 |
|---|---|
| Receipt number | R000066499 |
| Scientific Title | A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2025/06/25 16:11:28 |
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Basic information
Public title
A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals
Acronym
A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals
Scientific Title
A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals
Scientific Title:Acronym
A study for validation of muscular strength effects by beverages containing lactic acid bacteria in elderly individuals
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain data that clarifies the suppressive effect of test-food intake on grip strength decline and to elucidate its underlying mechanisms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip strength (measured value)
Key secondary outcomes
Grip strength classification (less than 28 kg for men, less than 18 kg for women), Muscle thickness (dominant forearm, right thigh), Muscle echo intensity (dominant forearm, right thigh), Muscle mass (sum of right and left arms; trunk; sum of right and left legs; sum of right and left arms and legs; sum of trunk, arms, and legs), Skeletal muscle mass index (SMI), Body fat mass, Phase angle (PhA), Extracellular water to total body water ratio (ECW/TBW), 4-meter walking speed, Five-times sit-to-stand test, Visual analog scale for fatigue (VAS), Blood NAD+ concentration, Hematological test parameters, Blood biochemical test parameters, Sleep assessment (OSA sleep inventory), Body weight, Body mass index (BMI)
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
Oral consumption of the test food (1 bottle, once daily) for 24 weeks
Interventions/Control_2
Oral consumption of the placebo food (1 bottle, once daily) 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 65 years or older at the time of consent acquisition.
2. Individuals with self-perceived physical decline.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals engaged in heavy lifting or other physically demanding work.
2. Individuals with irregular working hours, such as day-night shift.
3. Individuals who have suffered injuries affecting physical mobility, such as fractures or tendon ruptures, within the past year.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims (e.g., those containing lactic acid bacteria, or those claiming to alleviate fatigue), or health foods (including supplements) that may affect the outcomes of the trial, and who are unable to discontinue their use after providing informed consent.
5. Individuals who take supplements containing vitamin D, amino acids, or unsaturated fatty acids (DHA/EPA) regularly within the past three months and unable to discontinue.
6. Individuals who take drugs and quasi-drugs (e.g., nutritional supplements for fatigue, vitality, dementia medications, lactic acid bacteria preparations, gastrointestinal medications, antibiotics) regularly that may affect the outcomes of the trial, and are unable to discontinue their use.
7. Individuals who take steroids or hormones (e.g., compounds containing androgen or estrogen) within the last three months that may affect the outcomes of the trial, and are unable to discontinue their use.
8. Individuals with walking impairment in daily life, such as using cane.
9. Individuals with excessive alcohol intake.
10. Individuals with previous and/or current medical history of serious diseases in the severe cardiac, hepatic, renal, digestive, diabetes, rheumatoid arthritis and osteoarthritis.
11. Individuals with allergies to medications or food (particularly those with allergies to milk or soy).
12 Individuals with self-reported lactose intolerance.
13. Individuals who are participating in or have participated in a trial of pharmaceuticals or health foods within the four weeks prior to the current trial.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chukyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 06 | Month | 30 | 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 | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
14. Individuals who donated 200 mL of their blood or blood components within the last month.
15. Individuals who donated 400 mL of his blood within the last 3 months.
16. Individuals who donated 400 mL of her blood within the last 4 months.
17. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
18. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
19. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066499
