UMIN-ICDS Clinical Trial

Public title

Effects of test food on exercise-induced fatigue.

Acronym

Effects of test food on exercise-induced fatigue.

Scientific Title

Effects of test food on exercise-induced fatigue.

Scientific Title:Acronym

Effects of test food on exercise-induced fatigue.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effects of test food on exercise-induced fatigue.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

VAS(fatigue before and after excercise)

Key secondary outcomes

[1]VAS (fatigue upon waking)
[2]Maximal oxygen uptake
[3]Blood tests before and after the exercise test
[4]Heart rate before, during and after the exercise test
[5]Rating of perceived exertion during the exercise test

*Safety endpoints
[1]Subjects' diaries
[2]Occurrence of adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food(1 time in a day; 9days)

Interventions/Control_2

Placebo food(1 time in a day; 9days)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Meles and females aged 18 or older, and 60 under at the time of obtaining consent.
[2]Subjects who can safely perform the bicycle ergometer exercise without risk of falling.
[3]Subjects who have been fully informed of the purpose and content of this study, who are competent to give consent, who voluntarily volunteer to participate with understanding, and agree to participate in this study in writing.
[4]Subjects who are judged by the investigator to have no health problems in participating in this study.

Key exclusion criteria

[1]Subjects with a history of serious illness (liver, renal, cardiovascular, cerebrovascular, respiratory, etc.)
[2]Subjects who have joint contracture, orthopedic disease, pain, and so on, that limits the performance of motor tasks
[3]Subjects who have undergone surgical operations on the lower limbs and are currently undergoing treatment
[4]Subjects who have extremely irregular daily habits and eating habits
[5]Subjects who works in shifts or late at night exceed 0:00 AM
[6]Subjects with mental illness or dementia
[7]Subjects with allergies to food ingredients contained in the test food
[8]Subjects who are pregnant, lactating, or possibly pregnant
[9]Subjects who have donated component blood or more than 200 mL of whole blood in the month prior to the screening test, and who are scheduled to do during the test period
[10]Subjects currently participating in other human clinical trials. In addition, those who have participated in other clinical trials within the past 3 months, and the trials contents or test foods are conflict with those of this study
[11]Other subjects who are judged ineligible by the investigator

Target sample size

24

Name of lead principal investigator

1st name	Norio
Middle name
Last name	Hotta

Organization

Chubu University

Division name

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

Zip code

487-8501

Address

1200 Matsumoto, Kasugai, Aichi

TEL

0568-51-9667

Email

horinori@isc.chubu.ac.jp

Name of contact person

1st name	Norio
Middle name
Last name	Hotta

Organization

Chubu University

Division name

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

Zip code

487-8501

Address

1200 Matsumoto, Kasugai, Aichi

TEL

0568-51-9667

Homepage URL

Email

horinori@isc.chubu.ac.jp

Institute

Chubu University

Institute

Department

Personal name

Organization

Rohto Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Chubu University

Address

1200 Matsumoto, Kasugai, Aichi

Tel

0568-51-4424

Email

gakuji@offi ce.chubu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

10

Month

31

Day

Date of IRB

2023

Year

11

Month

08

Day

Anticipated trial start date

2023

Year

11

Month

16

Day

Last follow-up date

2024

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

09

Day

Last modified on

2023

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060053