UMIN-CTR Clinical Trial

Basic information
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
Condition	Healthy male adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	GN Corporation 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 06 Month 28 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 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
Other related information

Management information
Registered date	2020 Year 06 Month 24 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046681