UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of amino acid intake on physical condition
Title of the study (Brief title)	Effect of amino acid intake on physical condition
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Subjective evaluation (VAS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	R&D Division
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	KYOWA HAKKO BIO CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 08 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023675