UMIN-CTR Clinical Trial

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
Institute	CPCC Company Limited
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047815