UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029701
Receipt number R000033946
Scientific Title The effect of amino acids ingestion on physical fatigue after a single bout of exercise in healthy Japanese.
Date of disclosure of the study information 2017/11/01
Last modified on 2018/02/09 16:40:42

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Basic information

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

Condition

Healthy adults

Classification by specialty

Hepato-biliary-pancreatic medicine Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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.


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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


Address


Tel


Email



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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2017 Year 11 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name