UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021989
Receipt number R000025321
Scientific Title A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial.
Date of disclosure of the study information 2016/04/19
Last modified on 2017/03/02 16:25:08

* 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 study for evaluating the immunostimulating effect
-A Randomized, double-blind, placebo controlled trial.

Acronym

A study for evaluating the immunostimulating effect

Scientific Title

A study for evaluating the immunostimulating effect
-A Randomized, double-blind, placebo controlled trial.

Scientific Title:Acronym

A study for evaluating the immunostimulating effect

Region

Japan


Condition

Condition

Healthy adults who feel fatigue

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of test food on immune functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Scoring of Immunological Vigor after 4 weeks of intervention

Key secondary outcomes

Immunological parameters
Physical examinations
Urinary test
Blood test
Questionnaires (Likert)
:after 4 weeks of intervention


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



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food
Duration: 4 weeks
Dose: daily recommended dose
Usage: intake at optional timing

Interventions/Control_2

Placebo food
Duration: 4 weeks
Dose : daily recommended dose
Usage: intake at optional timing

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


Not applicable

Gender

Male and Female

Key inclusion criteria

a) Healthy adults, who feel fatigue
b) Persons whose ages are 20 years or older
c) Low immunity score (scoring immunological vigor: between 13 and 23) on visit 1's examination

Key exclusion criteria

a) Persons who have previous medical history of cancer, heart failure and cardiacinfarction
b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, digestive system disorder, autoimmune disorder, dyslipidemia, hypertension, and other chronic disease
c) Persons who takes medicines, herbal medicines, and dietary supplements
d) Persons who take in foods with an influence on Primary outcomes to more than three times a week in large quantities
e) Persons who take in foods with an influence on intestinal regulation to more than three times a week in large quantities
f) Persons who has allergy
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who enrolled in the other clinical trials within last 3 months before the agreement for the participation to the trial
i) Persons who investigator judge not suitable to participate in the trial

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name



Funding Source

Organization

Lotte Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seishin-kai medical Association Inc, Takara clinic.

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

医療法人社団 盛心会 タカラクリニック(東京都)
Seishin-kai Medical Association Inc, Takara clinic(Tokyo)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 19 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

2016 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 20 Day

Last follow-up date

2016 Year 08 Month 09 Day

Date of closure to data entry

2016 Year 08 Month 09 Day

Date trial data considered complete

2016 Year 09 Month 21 Day

Date analysis concluded

2016 Year 10 Month 12 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 19 Day

Last modified on

2017 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name