UMIN-CTR Clinical Trial

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