UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038034
Receipt number R000043358
Scientific Title A study of new exercise effects using anti-oxidative phenomenon by mitohormesis.
Date of disclosure of the study information 2019/09/18
Last modified on 2023/04/09 03:21:40

* 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

A study of new exercise effects using anti-oxidative phenomenon by mitohormesis.

Acronym

A study of new exercise effects using anti-oxidative phenomenon by mitohormesis.

Scientific Title

A study of new exercise effects using anti-oxidative phenomenon by mitohormesis.

Scientific Title:Acronym

A study of new exercise effects using anti-oxidative phenomenon by mitohormesis.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to demonstrate whether mitohormesis is observed or not by light exercise training to keep health.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of mRNA related mitohormesis by exercise(mRNA expressions of antioxidant-related gene(PGC-1a,SOD,catalase,GPx,NOX,XOR,arginase etc)and sulfide metabolizing enzyme-related(SQR,CARS2))

Key secondary outcomes

The association of individual life styles with marker related mitohormesis and Oxidative stress marker in blood (TBARS,NOx(NO2 and NO3),arginase etc).


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

[Group A:Total 14 people
(7people who have no exercise habits.
7people who have exercise habits.)]

Intervention(2weeks:5days/week)30min Jogging(about 5km)
-Cooling(2weeks)
-Non intervention(2weeks)

This study needs 6weeks.

Interventions/Control_2

[Group B:Total 14 people
(7people who have no exercise habits.
7people who have exercise habits.)]

Non intervention(2weeks)
-Cooling(2weeks)
-Intervention(2weeks:5days/week)30min Jogging(about 5km)

This study needs 6weeks.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People who have no exercise habits and exercise habits.
Subjects who sign an informed consent form to participate in this study .

Key exclusion criteria

People who don't agree.
People who are currently undergoing treatment.

Target sample size

28


Research contact person

Name of lead principal investigator

1st name Keiki
Middle name
Last name Ogino

Organization

Kochi Medical School

Division name

Department of Environmental Medicine

Zip code

783-8505

Address

Kohasu,Oko-cho,Nankoku-city,Kochi,Japan

TEL

0888882919

Email

kogino@kochi-u.ac.jp


Public contact

Name of contact person

1st name Keiki
Middle name
Last name Ogino

Organization

Kochi Medical School

Division name

Department of Environmental Medicine

Zip code

783-8505

Address

Kohasu,Oko-cho,Nankoku-city,Kochi,Japan

TEL

0888882919

Homepage URL


Email

kogino@kochi-u.ac.jp


Sponsor or person

Institute

Kochi Medical School
Department of Environmental Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kochi Medical School, Center for Next Generation Medicine

Address

Kohasu,Oko-cho,Nankoku-city,Kochi,Japan

Tel

0888802719

Email

im62@kochi-u.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

高知大学(高知県)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 18 Day


Related information

URL releasing protocol

https://krinri.cc.kochi-u.ac.jp/plan_ethical/app_form.php?id=ERB-108444

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jcbn/69/2/69_21-24/_article

Number of participants that the trial has enrolled

14

Results

Primary endpoint: SOD1 and SOD2 mRNA levels were significantly increased after exercise intervention compared to pre-exercise. Secondary endpoints: the oxidative stress marker MDA decreased slightly immediately after exercise and increased significantly after 2 weeks of exercise; the increase in SOD2 was independent of prior exercise habits, but at baseline, SOD2 was significantly higher in those with exercise habits than those without.

Results date posted

2023 Year 04 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Average age 23.4, male/female 11/3, no smoking habit, 7 with exercise habit

Participant flow

Participants were recruited for the Kochi University Environmental Medicine Practicum and 14 entered the program. Initially, a crossover study was planned, but due to departmental program constraints, only Intervention 1 was to be conducted instead of Intervention 2.

Adverse events

N/A

Outcome measures

Changes in mitohormesis-related markers by exercise intervention and their association with activity habits.
Antioxidant enzyme-related genes (PGC1a, SOD, catalase, GPx, NOX, XOR, arginase, etc.),
Oxidative stress markers in blood (TBARS, NOx (NO2 and NO3), arginase, etc.)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 11 Month 07 Day

Date of IRB

2019 Year 10 Month 30 Day

Anticipated trial start date

2019 Year 11 Month 07 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 03 Month 31 Day

Date trial data considered complete

2025 Year 03 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 18 Day

Last modified on

2023 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043358


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name