UMIN-CTR Clinical Trial

Public title

Effect of amino acid intake on physical condition

Acronym

Effect of amino acid intake on physical condition

Scientific Title

Effect of amino acid intake on physical condition

Scientific Title:Acronym

Effect of amino acid intake on physical condition

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of a 12-week amino acid intake on physical condition by a randomized, double-blind, placebo-controlled study.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Subjective evaluation (VAS)

Key secondary outcomes

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

Treatment

Type of intervention

Food

Interventions/Control_1

Placebo controls are taken before sleeping. This is to be continued for 12 weeks.

Interventions/Control_2

Amino acid supplements are taken before sleeping. This is to be continued for 12 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

Age-lower limit

40

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Healthy subjects aged from 40 to 60 years old
2)Subjects who have been working full-time (sedentary workers)
3)Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent

Key exclusion criteria

1)Subjects who have severe kidney, heart, liver, respiratory, endocrine or metabolic diseases
2)Subjects who have chronic fatigue syndrome, or have a severe fatigue, example for idiopathic chronic fatigue
3)Subjects who have moderate or more of seasonal allergic rhinitis (cedar, cypress)
4)Subjects who have a smoking habit
5)Subjects with a heavy alcohol consumption (>60 g/day)
6)Subjects whose BMI are less than 18.5, or 30 and more
7)Subjects who have the possibility of developing allergic symptoms by the test food
8)Subjects whose total score of Chalder Fatigue Scale is 19 or less, or 36 or more.
9)Subjects whose LF/HF score of autonomic nerve activities inspection is less than 1.5, or 10 or more
10)Subjects whose total power score of autonomic nerve activities inspection is less than 100 msec2
11)Subjects having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study
12)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
13)Subjects who have regular use habit of drugs for fatigue recovery, or quasi-drugs as the nutritional supplement at the time of physical fatigue
14)Subjects who have regular use habit of health foods or supplements containing amino acid.
15)Subjects deemed unsuitable by the investigator

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code

Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL

Email

sugino@soiken.com

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

KYOWA HAKKO BIO CO., LTD

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

Date of disclosure of the study information

2017

Year

06

Month

29

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

2015

Year

10

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

09

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

08

Day

Last modified on

2017

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023675