UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062045 |
|---|---|
| Receipt number | R000070990 |
| Scientific Title | Effects of Lactobacillus H61 Supplementation on Hemodynamic Responses After High-Intensity Resistance Exercise |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/24 16:49:55 |
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Basic information
Public title
Effects of 4-week Lactobacillus H61 supplementation on hemodynamic responses following resistance exercise
Acronym
Probiotic Supplementation and Resistance Exercise Study
Scientific Title
Effects of Lactobacillus H61 Supplementation on Hemodynamic Responses After High-Intensity Resistance Exercise
Scientific Title:Acronym
Probiotic Supplementation and Resistance Exercise Study
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 4-week Lactobacillus H61 supplementation on hemodynamic responses following high-intensity resistance exercise.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory markers
Key secondary outcomes
Cardiovascular function, renal ultrasound parameters, vascular endothelial function, blood, urinary, fecal, and salivary biomarkers, daily physical activity and sedentary behavior, body composition, sleep, mental health, and bodily pain.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
High-intensity resistance exercise and 4-week supplementation with Lactobacillus H61
Interventions/Control_2
High-intensity resistance exercise and 4-week supplementation with placebo
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 18 years or older
2) No current smoking habit
3) No medical contraindications to exercise
4) Not pregnant
5) No history of severe disease
6) No diagnosis of hypertension, arrhythmia, or diabetes mellitus
7) Able and willing to provide written informed consent
Key exclusion criteria
1) Individuals unable to perform resistance exercise using exercise equipment
2) Individuals unable to comply with the study requirements and pre-experimental instructions
3) Individuals with abnormal blood pressure or heart rate measured on the day of the experiment
4) Individuals deemed unsuitable for study participation by the investigators for any other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yoshikoshi |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
+81-29-853-5990
yoshikoshi.shun.ke@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yoshikoshi |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
Homepage URL
yoshikoshi.shun.ke@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
Name of secondary funder(s)
Tsukuba Industry Academia Collaboration Enhancement Project
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Health and Sport Sciences, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-29-853-2571
tg-kenkyurinri@un.tsukuba.ac.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 | 08 | 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 | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070990
