UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023587
Receipt number R000027165
Scientific Title The effects of amino acids mixture during exercise
Date of disclosure of the study information 2016/08/19
Last modified on 2017/02/09 11:19:27

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Basic information

Public title

The effects of amino acids mixture during exercise

Acronym

The effects of amino acids mixture during exercise

Scientific Title

The effects of amino acids mixture during exercise

Scientific Title:Acronym

The effects of amino acids mixture during exercise

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effects of amino acid mixture with placebo during exercise.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood cortisol

Key secondary outcomes

Questionnaire
Blood glucose
Blood ACTH
Blood CK
Blood lactate
Blood NH3
Blood free fatty acid
Blood total ketone bodies


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Exercise A after ingestion of test product-> Washout-> Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of test product
Washout-> Exercise B after ingestion of control product

Interventions/Control_2

Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of test product
Washout-> Exercise B after ingestion of test product

Interventions/Control_3

Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of test product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of control product

Interventions/Control_4

Exercise B after ingestion of control product-> Washout-> Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of control product
Washout-> Exercise A after ingestion of test product

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

40 years-old >

Gender

Male

Key inclusion criteria

1)Subjects who have given written informed consent
2)Healthy males aged 20 to 39 years old
3)Subjects whose BMI ranges from 18.5 to 25.0
4)Subjects whose blood cortisol increased during exercise at screening

Key exclusion criteria

1)Subjects with food allergies
2) Subjects having a smoking habit
3) Subjects who had blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study
4)Subjects who are currently participating in other clinical studies
5)Subjects who are judged as ineligible by the doctor for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuhisa Sakano

Organization

CPCC Company Limited

Division name

Clinical Reserch Planning Department

Zip code


Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Email

k.s@cpcc.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Ichinohe

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code


Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Homepage URL


Email

m.i@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

Meiji 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


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

チヨダパラメディカルケアクリニック(東京都)/Chiyoda Paramedical Care Clinic(Tokyo)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 19 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

2016 Year 07 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 20 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

2016 Year 08 Month 10 Day

Last modified on

2017 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=R000027165


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name