UMIN-CTR Clinical Trial

Public title

Exploratory trial of clinical effects by ingestion of beta-glucan-containing test-food

Acronym

Exploratory trial of clinical effects by ingestion of beta-glucan-containing test-food

Scientific Title

Exploratory trial of clinical effects by ingestion of beta-glucan-containing test-food

Scientific Title:Acronym

Exploratory trial of clinical effects by ingestion of beta-glucan-containing test-food

Region

Japan

Condition

Healthy male adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In order to verify some kind of clinical effect thoroughly by ingestion of beta-glucan with specific chemical structure

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Immunostimulation effects

Key secondary outcomes

1. Thrombogenesis-inhibitory effects
2. Inhibitory effects of blood-glucose level
3. Normalization effects of cholesterol level
4. Safety assessment

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the test food-A to the subjects, two packages a day (at breakfast and dinner) for 35 days.

Interventions/Control_2

Ingestion of the test food-A to the subjects, two packages a day (at breakfast and dinner) for 21 days.

Interventions/Control_3

Ingestion of the test food-A and the test food-B to the subjects for 35 days, two packages a day (at breakfast and dinner) and one package a day (at lunch), respectively.

Interventions/Control_4

Ingestion of the test food-A and the test food-B to the subjects for 21 days, two packages a day (at breakfast and dinner) and one package a day (at lunch), respectively.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

61

years-old

>

Gender

Male

Key inclusion criteria

(1) Healthy male subjects ranging in age from 40 to 60.
(2) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.

Key exclusion criteria

(1) Subjects with their body temperature of not less than 37.5 degree centigrade at the first coming to clinic.
(2) Subjects with any symptoms just like the common cold within two weeks before the first coming to clinic.
(3) Subjects with some kind of medical treatment.
(4) Subjects who have regularly took in health-specific / functional / health foods, containing a lot of beta-glucan, over three times a week.
(5) Subjects who have regularly took in immunostimulation foods, over three times a week.
(6) Subjects with previous medical history of drug and/or food allergy.
(7) Subjects who are now under the other clinical tests with some kind of medicines/foods, or participated those tests within four weeks after the current trial.
(8) Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial.
(9) Subjects who donated over 400 mL of their whole blood within the last three months to the current trial.
(10) Subjects who are going to 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.
(11) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Target sample size

16

Name of lead principal investigator

1st name	Yoshiko
Middle name
Last name	Amikura

Organization

GN Corporation Ltd.

Division name

President

Zip code

400-0866

Address

3-8 Wakamatsu-Cho, Kofu-shi, Yamanashi 400-0866, Japan

TEL

055-235-7527

Email

info@gncorporation.com

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

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

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

GN Corporation Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

06

Month

22

Day

Date of IRB

2020

Year

06

Month

19

Day

Anticipated trial start date

2020

Year

06

Month

29

Day

Last follow-up date

2020

Year

08

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

06

Month

24

Day

Last modified on

2021

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046681