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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012887
Receipt No. 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

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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
Email 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
Email koga@ks.kyorin-u.ac.jp

Sponsor
Institute C'est la vie Shinbashi Clinic, Medical Corporation Shinkokai
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015059

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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