UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Acronym	Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Scientific Title	Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Scientific Title:Acronym	Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine the effects on the immune function of Japanese males and females aged 20 and under 65 by continuously ingesting the test food for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wisconsin upper respiratory symptom survey-21 (WURSS-21)
Key secondary outcomes	POMS2 shortened version, peripheral blood image, NK cell activity, immunity evaluation, each item scores, flow cytometry analysis data, analysis data, secretory IgA

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	Prevention
Type of intervention	Food
Interventions/Control_1	8-week intake of the test food
Interventions/Control_2	8-week intake of the placebo food
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy Japanese male and female aged 20 years or older and younger than 65 years at the time of the informed consent. 2.Subject who is relatively high TMD score of POMS2 shortened version. 3.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1.Subject who is taking medication or under medical treatment because of some serious illness. 2.Subject who is under exercise therapy or dietetic therapy. 3.Subject who has an allergy for test food. 4.Subject who has or had a history of either medicine or alcohol dependence syndrome. 5.Subject who has or had a history of mental illness (depression) or sleep disturbance. 6.Subject who is on a night-shift worker. 7.Subject whose lifestyle is extremely irregular. 8.Subject who has an unbalanced diet. 9.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person. 10.Subject who uses drugs that may affect immune function (antibiotics, immunosuppressants, anti-inflammatory drugs, antirheumatic drugs, antihistamines, antiallergic drugs, lactic acid bacteria preparations, etc.) 11.Subject who uses health foods that affect immune function (such as yogurt products with functionality (immunity activation)), supplements, and pharmaceuticals 12.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13.Subject who performs intense exercises such as jogging, marathon and soccer 14.Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 15.Subject who is currently pregnant or lactating, or planning to get pregnant. 16.Subject who can't keep the daily records. 17.Subject who is judged to be inappropriate as test subject from clinical laboratory test values and measurement values at the time of SCR. 18.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	ASAHI CALPIS WELLNESS 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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.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	2020 Year 01 Month 14 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	2019 Year 07 Month 31 Day
Date of IRB	2019 Year 08 Month 13 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2020 Year 04 Month 02 Day
Date of closure to data entry	2020 Year 04 Month 23 Day
Date trial data considered complete	2020 Year 04 Month 23 Day
Date analysis concluded	2020 Year 07 Month 23 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 19 Day
Last modified on	2020 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043987