UMIN-CTR Clinical Trial

Public title

The effect of amino acids ingestion on physical fatigue after a single bout of exercise in healthy Japanese.

Acronym

The effect of amino acids ingestion on physical fatigue after exercise in healthy Japanese.

Scientific Title

The effect of amino acids ingestion on physical fatigue after a single bout of exercise in healthy Japanese.

Scientific Title:Acronym

The effect of amino acids ingestion on physical fatigue after exercise in healthy Japanese.

Region

Japan

Condition

Healthy adults

Classification by specialty

Hepato-biliary-pancreatic medicine	Not applicable	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To elucidate the effect of amino acids ingestion on physical fatigue and physical function after a single bout of exercise in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Evaluation of physical function, physical fatigue and blood biomarkers for 4 days following a single bout of exercises.

Key secondary outcomes

Questionnaire on physical condition etc. for 4 days following a single bout of exercises.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food	Behavior,custom

Interventions/Control_1

Intake of amino acids (control) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day. Establish a 3-week washout period. Intake of amino acids (active) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day.

Interventions/Control_2

Intake of amino acids (active) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day. Establish a 3-week washout period. Intake of amino acids (control) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day.

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

20

years-old

<=

Age-upper limit

39

years-old

>=

Gender

Male

Key inclusion criteria

-A person who hasn't had a motor dysfunction.
-A person who is able to participate in a functional fitness test.
-A person who hasn't used a cardiac pacemaker and/or an artificial joint.

Key exclusion criteria

-A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system.
-A person who has had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year.
-A person who has had dietary allergy.
-A person who has had a habit to do strength training.
-A person who has been ordered not to do exercise by a medical doctor.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihiko Minegishi

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7817

Email

minegishi.yoshihiko@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Kotaro Tamura

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7687

Homepage URL

Email

tamura.kotaro@kao.co.jp

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（栃木県）

Date of disclosure of the study information

2017

Year

11

Month

01

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

Completed

Date of protocol fixation

2017

Year

10

Month

30

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

25

Day

Last modified on

2018

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033946