UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054363 |
|---|---|
| Receipt number | R000062076 |
| Scientific Title | The effect of lactic acid bacteria ingestion combined with resistance training on muscle hypertrophy |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/04/02 16:32:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of lactic acid bacteria ingestion combined with resistance training on muscle hypertrophy
Acronym
The effect of lactic acid bacteria ingestion combined with resistance training on muscle hypertrophy
Scientific Title
The effect of lactic acid bacteria ingestion combined with resistance training on muscle hypertrophy
Scientific Title:Acronym
The effect of lactic acid bacteria ingestion combined with resistance training on muscle hypertrophy
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of lactic acid bacteria ingestion during 12 weeks of resistance training on muscle hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle mass
Key secondary outcomes
Body composition
Abdominal visceral fat mass
Inflammation-related biomarkers
Intestinal flora
Muscle soreness
Safety assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Resistance training (2 times per week)
Ingestion of low dose lactic acid bacteria powder, twice per day, 12 weeks
Interventions/Control_2
Resistance training (2 times per week)
Ingestion of high dose lactic acid bacteria powder, twice per day, 12 weeks
Interventions/Control_3
Resistance training (2 times per week)
Ingestion of placebo powder, twice per day, 12 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Subjects who can give informed consent to participate in this study
2.Males aged 30 to 59 years old
3.Subjects who perform exercises at least once a month
Key exclusion criteria
1. Subjects who have a chronic medical condition undergoing treatment, or who have a history of a serious illness
2. Subjects who have a disease that causes temporary muscle spasms or loss of consciousness
3. Subjects who have significant orthopedic injuries
4. Subjects who restricted exercise or bathing due to medical reasons
5. Subjects who are allergic to milk, wheat, orange, beef, sesame, soy, chicken, banana, apple, or gelatin
6. Subjects who use drugs that may affect the results of the study
7. BMI<18.5, BMI>=30
8. Smoker
9. Heavy drinkers
10. Subjects who perform resistance training using barbells, dumbbells or machines at least once a week
11. Subjects who participate other clinical studies
12. Subjects who are judged as unsuitable for the study by the principal investigator for other reason
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Sanbongi |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
+81-42-632-5847
chiaki.sanbongi@meiji.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yoshimura |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
+81-42-632-5847
Homepage URL
aya.yoshimura.aa@meiji.com
Sponsor or person
Institute
Meiji 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
Ritsumeikan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F, Daiwa Bldg.3-3-10 Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
MIJ24C4
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社 明治 研究本部
(R&D Division, Meiji Co., Ltd.)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 11 | 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
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062076
