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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016647
Receipt No. R000018901
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
Date of disclosure of the study information 2015/03/21
Last modified on 2016/08/29

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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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