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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033953
Receipt No. R000038718
Scientific Title Evaluation of immunostimulatory effects of foods
Date of disclosure of the study information 2018/09/18
Last modified on 2019/06/27

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Basic information
Public title Evaluation of immunostimulatory effects of foods
Acronym Evaluation of immunostimulatory effects of foods
Scientific Title Evaluation of immunostimulatory effects of foods
Scientific Title:Acronym Evaluation of immunostimulatory effects of foods
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the immunostimulatory effects of the foods on CD69 and other markers expression on T cells
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CD69 expression on T cells
Key secondary outcomes Expressions of activation markers on T cells
Expressions of senescence markers on T cells
Lymphocyte blastoid transformation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of the test food (112 mL) once a day for 3 weeks
Interventions/Control_2 Oral intake of the placebo (112mL) once a day for 3 weeks
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects who have given written informed consent
2) Subjects aged 30 to 65 years old
3) Subjects whose body mass index (BMI) is from 18.5 kg/m2 to 24.9 kg/m2
4) Subjects who have not received a vaccination within the past half year and are not planning to get a vaccination during the study.
Key exclusion criteria 1) Subjects who have immune related diseases or its medical histories
2) Cancer patients
3) Subjects who have psychological diseases
4) Subjects who have infectious diseases
5) Subjects who have asthma, food allergy, atopic dermatitis or their medical histories
6) Subjects who intake anti-inflammatory drugs, immunosuppressants, antibiotics, anti-allergic drugs
7) Subjects who are pregnant, or wish to be pregnant during the study
8) Lactating women
9) Subjects who are intolerant to lactose
10) Smokers
11) Subjects who have a habit to take alcohol(expressed in amount of alcohol: over 60 g/day)
12) Subjects who have a habit to take fermented milks, foods for specified health use, or dietary supplements containing probiotics more than once a day
13) Subjects who have a habit to take pharmaceuticals, health foods or dietary supplements containing ingredients can affect immune system more than 3 times a week within past 2 weeks
14) Subjects who have participated in other clinical trials within a month or plan to participate other clinical trials during this study period
15) Subjects who are judged not suitable to participate in this trial by principal investigator or subinvestigators
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Asami
Organization Meiji Co., Ltd.
Division name Food Microbiology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5842
Email yukio.asami@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Seiya Makino
Organization Meiji Co., Ltd.
Division name Food Microbiology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5842
Homepage URL
Email seiya.makino@meiji.com

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Meiji 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
Address
Tel
Email

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 チヨダパラメディカルケアクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 18 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
2018 Year 08 Month 29 Day
Date of IRB
2018 Year 08 Month 29 Day
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
2018 Year 11 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 06 Month 27 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038718

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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