UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044722
Receipt number R000050905
Scientific Title The study for the effects of food containing lactic acid bacteria on delayed onset muscle soreness
Date of disclosure of the study information 2021/07/01
Last modified on 2023/07/10 18:09:42

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Basic information

Public title

The study for the effects of food containing lactic acid bacteria on delayed onset muscle soreness

Acronym

The study for the effects of food containing lactic acid bacteria on delayed onset muscle soreness

Scientific Title

The study for the effects of food containing lactic acid bacteria on delayed onset muscle soreness

Scientific Title:Acronym

The study for the effects of food containing lactic acid bacteria on delayed onset 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 test food 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

2

Purpose of intervention

Treatment

Type of intervention

Food Maneuver

Interventions/Control_1

Intake test food (containing lactic acid bacteria)for 3weeks (1 capsule per day) and stretch biceps brachii after delayed onset muscle soreness induced

Interventions/Control_2

Intake placebo food (not containing lactic acid bacteria) for 3weeks (1 capsule per day) and stretch biceps brachii after delayed onset muscle soreness induced

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

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

10


Research contact person

Name of lead principal investigator

1st name Takaya
Middle name
Last name Narita

Organization

Toin University of Yokohama

Division name

Department of Sport Technology Faculty of Culture and Sport Policy

Zip code

225-8503

Address

1614 Kurogane-cho, Aoba-ku, Yokohama Kanagawa prefecture

TEL

+81-45-974-5792

Email

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

Department of Sport Technology Faculty of Culture and Sport Policy

Zip code

225-8503

Address

1614 Kurogane-cho, Aoba-ku, Yokohama Kanagawa prefecture

TEL

+81-45-974-5792

Homepage URL


Email

t-narita@toin.ac.jp


Sponsor or person

Institute

Toin University of Yokohama

Institute

Department

Personal name



Funding Source

Organization

JAPAN SPORT COUNCIL

Organization

Division

Category of Funding Organization

Government offices of other countries

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 Kanagawa prefecture

Tel

+81-45-974-5605

Email

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

2021 Year 07 Month 01 Day


Related information

URL releasing protocol

https://search.yahoo.co.jp/search

Publication of results

Unpublished


Result

URL related to results and publications

https://search.yahoo.co.jp/search

Number of participants that the trial has enrolled

9

Results

In some items, the possibility of lactic acid bacteria was suggested, but the difference was not sufficient in any of the items, and future verification is needed.

Results date posted

2023 Year 07 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were 12 male students affiliated with Toin University of Yokohama who completed the prescribed schedule. Of these 12 subjects, those who did not show any muscle weakness after the muscle soreness onset load and may not have induced muscle soreness, and 3 subjects (1 lactobacillus and 2 placebo) whose number of sets exceeded 10 sets in the muscle soreness onset load and whose 1RM setting may be low were excluded from the analysis, and 9 subjects were included in the analysis.

Participant flow

Muscle mass is measured as a pre-test. Pre measurements were taken up to 15 days prior to the onset of muscle soreness, and evaluations were made the day before the onset of muscle soreness, immediately after the onset of muscle soreness, 1 hour, 24 hours, 48 hours, and 1 week after the onset of muscle soreness.

Adverse events

nothing in particular

Outcome measures

Elbow joint flexion/extension range of motion and angular velocity
The subjects were instructed to flex and extend their elbow joints at the maximum range of motion in the submaximal position of the shoulder joint and were videotaped. The elbow joint flexion/extension range of motion and angular velocity were analyzed using DIPP-MotionV2D (Detect, Inc.). Measurements were taken three times and the average value was calculated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2021 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2021 Year 07 Month 20 Day

Last follow-up date

2021 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

2021 Year 07 Month 01 Day

Last modified on

2023 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name