UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034290
Receipt number R000039091
Scientific Title The effect of endurance exercise training by liver extract in healthy subjects: randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2020/10/01
Last modified on 2021/01/18 14:11:53

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Basic information

Public title

The effect of endurance exercise training by liver extract in healthy subjects: randomized, double-blind, placebo-controlled trial

Acronym

The effect of endurance exercise training by liver extract

Scientific Title

The effect of endurance exercise training by liver extract in healthy subjects: randomized, double-blind, placebo-controlled trial

Scientific Title:Acronym

The effect of endurance exercise training by liver extract

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effect of endurance exercise training by oral liver extract

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VO2 max, anti-oxidative level, performance test

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

Interventions/Control_1

Test food for 4 weeks

Interventions/Control_2

Placebo food for 4 weeks

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 and Female

Key inclusion criteria

(1) Subjects aged 18 to 30 years on the day of signing the informed consent
(2) Healthy subjects who do not have severe disease in cardiovascular system
(3) Subjects who have received written informed consent

Key exclusion criteria

(1) Subjects who have history of severe disease
(2) Subjects who are treated with medicine, intervention of exercise or diet by doctor
(3) Subjects who are judged as inappropriate by investigator and doctor

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Norio
Middle name
Last name Hotta

Organization

Chubu University

Division name

Department of Lifelong Sports for Health College of Life and Health Sciences

Zip code

487-8501

Address

1200 Matsumoto-cho, Kasugai-shi, Aichi

TEL

0568-51-9667

Email

horinori@isc.chubu.ac.jp


Public contact

Name of contact person

1st name Norio
Middle name
Last name Hotta

Organization

Chubu University

Division name

Department of Lifelong Sports for Health College of Life and Health Sciences

Zip code

487-8501

Address

1200 Matsumoto-cho, Kasugai-shi, Aichi

TEL

0568-51-9667

Homepage URL


Email

horinori@isc.chubu.ac.jp


Sponsor or person

Institute

Chubu University

Institute

Department

Personal name



Funding Source

Organization

ZERIA Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Chubu University

Address

1200 Matsumoto-cho, Kasugai-shi, Aichi

Tel

0568-51-1111

Email

horinori@isc.chubu.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

2020 Year 10 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

Completed

Date of protocol fixation

2018 Year 07 Month 10 Day

Date of IRB

2018 Year 07 Month 10 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2021 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 27 Day

Last modified on

2021 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039091


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name