UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048164 |
|---|---|
| Receipt number | R000054658 |
| Scientific Title | The study for the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2023/12/25 12:03:21 |
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Basic information
Public title
The study for the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness
Acronym
The study for the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness
Scientific Title
The study for the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness
Scientific Title:Acronym
The study for the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Lactiplantibacillus plantarum 22A-3 on muscle soreness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Elbow flexor /extension range of motion, /angular velocity (rad/s)
2.Pain assessment (pressure pain, concentric contraction, and eccentric contraction)
3.Muscle hardness
4.Sliding assessment
5 Elbow flexor maximal isometric strength (Nm)
Key secondary outcomes
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
4
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Take test food (with Lactiplantibacillus plantarum 22A-3)for 22 days (1 capsule per day).
Interventions/Control_2
Take placebo food (without Lactiplantibacillus plantarum 22A-3) for 22days (1 capsule per day).
Interventions/Control_3
After muscle soreness is induced, cupping on one upper limb.
Interventions/Control_4
Take placebo food (without Lactiplantibacillus plantarum 22A-3) for 22days (1 capsule per day).
After muscle soreness is induced, without capping on the other upper limb as control.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
(1)Subjects who have a medical history or present illness of an Orthopedic Diseases on the upper limbs
(2)Subjects who continuously perform exercises using the upper limbs for at least one hour once a week
(3)Subject who have an allergy for test food
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Narita |
Organization
Toin University of Yokohama
Division name
graduate school of sport sciences
Zip code
225-8503
Address
1614 Kurogane-cho, Aoba-ku, Yokohama
TEL
+81-45-974-5792
t-narita@toin.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Narita |
Organization
Toin University of Yokohama
Division name
graduate school of sport sciences
Zip code
225-8503
Address
1614 Kurogane-cho, Aoba-ku, Yokohama
TEL
+81-45-974-5792
Homepage URL
t-narita@toin.ac.jp
Sponsor or person
Institute
Toin University of Yokohama
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Maruzen Pharmaceuticals Co., Ltd.
IRB Contact (For public release)
Organization
Toin University of Yokohama Clinical Research Ethics Review Committee
Address
1614 Kurogane-cho, Aoba-ku, Yokohama
Tel
045-974-5605
research@toin.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
桐蔭横浜大学（神奈川県）Toin University of Yokohama（KANAGAWA）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | 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
| 2022 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054658
