UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the milk drink on immunity index for healthy adults
Acronym	The effect of the milk drink on immunity index for healthy adults
Scientific Title	The effect of the milk drink on immunity index for healthy adults: A double-blind, randomized, controlled parallel group study
Scientific Title:Acronym	The effect of the milk drink on immunity index for healthy adults: A double-blind, randomized, controlled parallel group study
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of a milk drink on immunity index of healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Immunity index
Key secondary outcomes

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Fermented milk drink 1 bottle/day for 43 days
Interventions/Control_2	Unfermented milk drink 1 bottle/day for 43 days
Interventions/Control_3
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male
Key inclusion criteria	1. Males aged 30 to 49 years when informed consent. 2. Subjects who work within office buildings. 3. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	1. Subjects who tested positive for SARS-CoV-2 before the screening, who tested positive for hepatitis B virus, hepatitis C virus, syphilis and human immunodeficiency virus in the screening. 2. Subjects who themselves or family living together tested positive for SARS-CoV-2, or have a fever of 37.5 degrees or higher within the last four weeks. 3. Subjects who are planning to receive the COVID-19 vaccine during the trial. 4. Subjects who have diseases which are difficult to differentiate from upper respiratory infection by themselves. 5. Subjects who have abdominal symptoms by ingesting dairy products. 6. Subjects who constantly intake fermented dairy products and/or lactic acid bacteria preparation. 7. Subjects who constantly use food for specified health use, functional foods, supplements, and/or healthy food having a possibility of affecting the result of this trial. 8. Subjects who have previous and/or current medical history of serious disease. 9. Subjects who with heavy use of alcohol, and heavy smoking. 10. Subjects who have extremely irregular dining habits. 11. Subjects who are participating the other clinical tests, who participated the other clinical tests within 4-weeks prior to the current study. 12. Subjects who have previous medical history of drug and/or food, allergy, especially for milk. 13. Subjects who donated over 200mL blood and/or blood components within the last one month. 14. Subjects who donated over 400mL blood and/or blood components within the last three month. 15. Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 16. Others who have been determined ineligible by principal investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Shukuko Middle name Last name Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Doctor
Zip code	101-0047
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-5548
Email	s.s@cpcc.co.jp

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	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-3112
Homepage URL
Email	m.n@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Yakult Honsha 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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo
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 07 Month 20 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	2021 Year 06 Month 28 Day
Date of IRB	2021 Year 06 Month 18 Day
Anticipated trial start date	2021 Year 07 Month 21 Day
Last follow-up date	2021 Year 09 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 09 Day
Last modified on	2022 Year 06 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051174