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

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 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


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

Value
https://center6.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