UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levels
Acronym	A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levels
Scientific Title	A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levels
Scientific Title:Acronym	A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levels
Region	Japan

Condition
Condition	None
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the synergistic effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levels
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood arginine and NOx levels
Key secondary outcomes	Blood cGMP, 8-isoprostane, MDA-LDL, and triglyceride levels

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The administration of the test food containing L-citrulline and L-arginine
Interventions/Control_2	The administration of the test food containing L-citrulline
Interventions/Control_3	The administration of the test food containing L-arginine
Interventions/Control_4	The administration of placebo control
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	49 years-old >=
Gender	Male
Key inclusion criteria	1) Healthy male subjects aged from 20 to 49 years old 2) Subjects whose BMI are 25 or over less than 30 kg/m2 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 regularly take any drugs for cardiovascular or circulatory organs system 2) Subjects who have a history of heart diseases 3) Subjects who have severe liver, kidney, heart, respiratory, endocrine or metabolic diseases 4) Subjects who have a smoking habit 5) Subjects with a heavy alcohol consumption (>60 g/day) 6) Subjects who have an intake of Citrulline or Arginine 7) Subjects who take any drugs for improving circulating 8) Subjects who have the possibility of developing allergic symptoms by the test food 9) Subject 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 10)Subject 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 11) Subject deemed unsuitable by the investigator
Target sample size	40

Research contact person
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

Public contact
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

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)

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	ふくだ内科クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 21 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	2015 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 21 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	2015 Year 02 Month 26 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018901

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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