UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051902 |
|---|---|
| Receipt number | R000059198 |
| Scientific Title | A study for validation of anti- frail effects by beverages containing lactic acid bacteria |
| Date of disclosure of the study information | 2024/08/15 |
| Last modified on | 2024/10/22 17:46:40 |
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Basic information
Public title
A study for validation of anti- frail effects by beverages containing lactic acid bacteria
Acronym
A study for validation of anti- frail effects by beverages containing lactic acid bacteria
Scientific Title
A study for validation of anti- frail effects by beverages containing lactic acid bacteria
Scientific Title:Acronym
A study for validation of anti- frail effects by beverages containing lactic acid bacteria
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm some kind of effect by the test-food intakes for 24 weeks on physical function and cognitive function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty indicators (grip strength, gait speed, body weight)
Key secondary outcomes
Muscle mass (trunk, right arm + left arm, right leg + left leg), skeletal muscle index, bone mineral density, 6-minute walk test, chair stand up test, knee extension strength, fatigue VAS, blood biochemical tests, cognitive function, gut microbiota by 16S rRNA gene amplicon sequencing, stool and blood short-chain fatty acid analysis, urine and saliva and blood proteome analysis, intraocular pressure, olfaction, acceleration plethysmography, grip strength, 4-meter walking speed, body weight, 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
Consumption of the test food (1 bottle a day) for 24 weeks
Interventions/Control_2
Consumption of the placebo food (1 bottle a day) 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects aged 50 years or older at informed consent.
(2) Subjects with self-perceived physical decline.
(3) Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail
Key exclusion criteria
Subjects-
(1) engaged in heavy lifting or other physically demanding work
(2) with irregular working hours, such as day-night shift
(3) who have suffered injuries affecting physical mobility, such as fractures or tendon ruptures, within the past year
(4) who take regularly the FOSHU, Foods with functional claims (e.g., containing lactic acid bacteria, claiming to reduce fatigue and improve cognitive function) and health food which might affect the test results
(5) who take supplements containing Ca, vitamin D, amino acids, or unsaturated fatty acids (DHA/EPA) regularly within the past 6 months and unable to discontinue
(6) who take drugs and quasi-drugs (e.g., nutritional supplements for fatigue, vitality, dementia medications, lactic acid bacteria preparations, gastrointestinal medications, antibiotics) and unable to discontinue
(7) who take steroids or hormone (e.g., compounds containing androgen or estrogen) within the last 6 months and unable to discontinue
(8) with walking impairment in daily life, such as using cane
(9) who take excessive alcohol
(10) who have previous/current medical history of severe cardiac, hepatic, renal, digestive, rheumatoid arthritis and osteoarthritis
(11) pregnant, possibly pregnant, or lactating
(12) having drug and/or food allergy
(13) with self-reported lactose intolerance
(14) who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this research, or will participate in that after giving informed consent to take part in this research
(15) donated blood or component (0.2 L) within the last 1 months
(16) donated his blood (0.4 L) within the last 3 months
(17) donated her blood (0.4 L) within the last 4 months
(18) being collected in total of his blood (1.2 L) within the last 12 months and in this research
Target sample size
60
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 103-0021, 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 103-0021, 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
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
| 2024 | Year | 08 | Month | 15 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
(19) being collected in total of her blood (0.8 L) within the last 12 months and in this research
(20) who judged as ineligible for participation by the principal/sub investigator
Management information
Registered date
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059198
