UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027372
Receipt number R000031365
Scientific Title A verification study of improvements in the immune activation: an open trial
Date of disclosure of the study information 2017/05/17
Last modified on 2017/10/10 07:44:34

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Basic information

Public title

A verification study of improvements in the immune activation: an open trial

Acronym

A verification study of improvements in the immune activation

Scientific Title

A verification study of improvements in the immune activation: an open trial

Scientific Title:Acronym

A verification study of improvements in the immune activation

Region

Japan


Condition

Condition

Healthy Japanese adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of the test beverage on immune activation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Scoring of immunological vigor
*Assess at 0 and 4 weeks after consuming

Key secondary outcomes

Immunity test
T lymphocyte age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD4+T cells, CD8+T cells, CD8+CD28+T cells, memory T cells
*Assess at 0 and 4 weeks after consuming


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test beverage: Kiseisui
Dose and direction: Drink 30 mL before the dinner
*If you forget to drink the test beverage drink it between after dinner to before going to bed

Interventions/Control_2


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

40 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Japanese people who are 40 or more to less than 70 years old with experiencing fatigue

2. Those who are considered as appropriate for the study by the physician

3. Within 2, Priority selection is made in the order of II: warning zone, III: observation zone, and IV: safety zone, in immunological grade at baseline, and V: sufficiently high and I: critical zone are excluded

Key exclusion criteria

1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Those who are smokers

5. Currently taking medicines and/or herbal medicines

6. Those who are allergic to medicines, milk, beans, orange, and/or other food products

7. Those who are pregnant, breast-feeding, and plan to become a pregnant

8. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

9. Others considered as inappropriate for the study by the physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, 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

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, 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

UTP 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 Medical 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 Medical Clinic (Tokyo)


Other administrative information

Date of disclosure of the study information

2017 Year 05 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

Completed

Date of protocol fixation

2017 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 18 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

2017 Year 05 Month 17 Day

Last modified on

2017 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name