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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | None | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |