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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040882
Receipt No. R000046681
Scientific Title Exploratory trial of clinical effects by ingestion of beta-glucan-containing test-food
Date of disclosure of the study information 2021/06/28
Last modified on 2021/03/01

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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