UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016647 |
|---|---|
| Receipt number | 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 08:50:28 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018901
