UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014278
Receipt number R000016280
Scientific Title A clinical study for evaluating the effect of L-citrulline on physical performance
Date of disclosure of the study information 2014/06/16
Last modified on 2015/01/21 18:14:08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A clinical study for evaluating the effect of L-citrulline on physical performance

Acronym

A clinical study for evaluating the effect of L-citrulline on physical performance

Scientific Title

A clinical study for evaluating the effect of L-citrulline on physical performance

Scientific Title:Acronym

A clinical study for evaluating the effect of L-citrulline on physical performance

Region

Japan


Condition

Condition

None

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of L-citrulline intake for 8 days on physical performance

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

4km cycling time trial performance

Key secondary outcomes

bloodchemisty(NOx), VO2 and visual analogue scale


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Effectiveness after 8 days of
test food consumption compared to placebo control

Interventions/Control_2

Effectiveness after 8 days of
test food consumption compared to base line

Interventions/Control_3


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

20 years-old <=

Age-upper limit

39 years-old >=

Gender

Male

Key inclusion criteria

1) Subject, aged from 20 to 39 years (bounds included)
2) Subject having sports with lower limbs more than 2 days a week
3) Subject classified as more than good grade of the PWC75%HRmax score on the physical work capacity on a cycle ergometer
4)Subject who can have a cycle ergometer exercise with more than 60 rpm for 12 minutes at the torque in case of 60 rpm of PWC75%HRmax
5) Subject having 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) Subject taking any medical treatment(prescribed a medicine by a doctor)
2) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3) Subject having a medical history of a chest pain or swoon career
4) Subject having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
5) Subject having an abnormality in the electrocardiogram
6) Subject having the possibilty of developing allergic symptoms by test food
7) 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
8) Subject having the habit of taking a supplement
9) Subject received a serious injury within past 1 year
10) Subject taking part in any sports events during the present study period or within 1 month before and after the period
11) Subject going abroad or having a trip for more than 3 days and 2 nights during the present study
12) Subject having a smoking habit
13) Subject having a seasonal allergy of a cedar or Japanese cypress pollen
14) Subject who took part in another clinical trial within 3 months prior to the start of the present study or who is currently taking part in another clinical trial
15) Subject judged to be ineligible by the investigator for other reason

Target sample size

20


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

Email

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


Email

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


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

ふくだ内科クリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 16 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

2014 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 10 Month 07 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 16 Day

Last modified on

2015 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016280


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name