UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012887 |
|---|---|
| Receipt number | R000015059 |
| Scientific Title | The effect of L-citrulline on human cognitive function: a randomized, double-blind, parallel-group comparative study. |
| Date of disclosure of the study information | 2014/01/17 |
| Last modified on | 2014/01/17 20:06:01 |
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Basic information
Public title
The effect of L-citrulline on human cognitive function: a randomized, double-blind, parallel-group comparative study.
Acronym
The effect of L-citrulline on human cognitive function.
Scientific Title
The effect of L-citrulline on human cognitive function: a randomized, double-blind, parallel-group comparative study.
Scientific Title:Acronym
The effect of L-citrulline on human cognitive function.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of L-citrulline on human cognitive function. We conduct simultaneous recordings of changes of oxy-hemoglobin concentration by near-infrared spectroscopy and the event-related potentials during the performance of cognitive tasks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) The changes in the oxy-Hb concentration and amplitudes and latencies of P300 of event-related potentials
2) Performance of the tasks
3) Psychological tests by using the visual analog scale (VAS)
Key secondary outcomes
1) vital signs (blood pressure and heart rate)
2) blood test (white blood cell count, red blood cell count, hemoglobin, hematocrit, and platelet count)
3) serum chemistry test (serum total protein, albumin, AST, ALT, LDH, gamma-GTP, urea nitrogen (UN), creatinine, uric acid (UA), sodium, chloride, potassium, total cholesterol, LDL cholesterol, HDL cholesterol, and blood glucose)
4) urinalysis (occult blood, urinary protein, urinary glucose, and urobilinogen)
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
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Sample and dose: L-citrulline 5600mg/day
period: 8 days
Interventions/Control_2
Sample and dose: L-citrulline 800mg/day and cellulose 4800mg/day
period: 8 days
Interventions/Control_3
Sample and dose: cellulose 5600mg/day (placebo)
period: 8 days
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
| 50 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy and right-handed subjects.
In female subjects, menopose occurred more than 6 months ago.
Key exclusion criteria
1) regular medication for circulation system and central nerves system
2) history of psychiatric disorders or cerebrovascular diseases
3) serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases
4) marked abnormal findings for blood and urine tests
5) smoker
6) heavy drinker of alcohol
7) obesity (BMI >= 30)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Koga |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
koga@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Koga |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
koga@ks.kyorin-u.ac.jp
Sponsor or person
Institute
C'est la vie Shinbashi Clinic, Medical Corporation Shinkokai
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2014 | Year | 01 | Month | 17 | Day |
Last modified on
| 2014 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015059
