UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041891
Receipt number R000047815
Scientific Title Confirmation study of immunostimulation effects by test-food intake
Date of disclosure of the study information 2021/09/29
Last modified on 2021/09/14 22:52:47

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Basic information

Public title

Confirmation study of immunostimulation effects by test-food intake

Acronym

Confirmation study of immunostimulation effects by test-food intake

Scientific Title

Confirmation study of immunostimulation effects by test-food intake

Scientific Title:Acronym

Confirmation study of immunostimulation effects by test-food intake

Region

Japan


Condition

Condition

Healthy male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to discuss some kind of immunostimulation effect by test-food intakes for 6 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Variations in influenza-antibody titer

Key secondary outcomes

1. High sensitive IL-4
2. High sensitive IFN-gamma
3. NK cell activity
4. Secretary IgA in saliva


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

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Continuous consumption of
the RHAMNOX (200 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.

Interventions/Control_2

Continuous consumption of
the RHAMNOX (100 mg)-containing test-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.

Interventions/Control_3

Continuous consumption of
the placebo-food capsule to the volunteers, once a day (after breakfast) for 6 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Healthy male/female volunteers of not less than 50 years old.
(2) Volunteers who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.

Key exclusion criteria

(1) Volunteers with influenza-virus infection within a year before giving informed consent to take part in this trial.
(2) Volunteers with influenza vaccination recently at the point of giving informed consent to take part in this trial.
(3) Volunteers with previous history of some kind of symptom just like anaphylactic shock, which was caused by influenza vaccination.
(4) Volunteers taking steadily in the medicine, which might affect the test results.
(5) All through this trial, volunteers who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect the test results.
(6) Pregnant, possibly pregnant, or lactating women.
(7) Volunteers with present/previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(8) Volunteers with excessive alcohol intake.
(9) Volunteers with heavy smoking.
(10) Volunteers with extremely irregular life rhythms, midnight work and/or irregular shift one.
(11) Volunteers with drug and/or food allergy.
(12) Volunteers who are now under the other clinical tests with some kind of medicines/foods, or took part in those tests within four weeks after this trial.
(13) Volunteers who donated over 200 mL of their whole blood and/or blood components within a month into this trial.
(14) Males who donated over 400 mL of their whole blood within the last three months into this trial.
(15) Females who donated over 400 mL of their whole blood within the last four months into this trial.
(16) Males who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(17) Females who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(18) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Terasawa

Organization

KONAN CHEMICAL MANUFACTURING Co Ltd.

Division name

Acting Manager

Zip code

510-0103

Address

1515 Kusu-Cho-Kita-Gomizuka, Yokkaichi-shi, Mie 510-0103, Japan

TEL

059-397-2612

Email

info@konanchemical.co.jp


Public contact

Name of contact person

1st name Mitsuhiro
Middle name
Last name Fujimoto

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

KONAN CHEMICAL MANUFACTURING 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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp


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

2021 Year 09 Month 29 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

2020 Year 09 Month 23 Day

Date of IRB

2020 Year 09 Month 18 Day

Anticipated trial start date

2020 Year 09 Month 29 Day

Last follow-up date

2020 Year 12 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 24 Day

Last modified on

2021 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047815