UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Title of the study (Brief title)	Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Region	Japan

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

Objectives
Narrative objectives1	An objective is to examine an influence of continuous intake of a test food product on a blood immune marker and a feeling of fatigue by selecting males and females aged 40 and over, below 60 as subjects and assigning them to take the test food product for 8 weeks on a continuous basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	1.Number of each leukocyte subset 2.T-cell blastogenesis 3.NK activity 4.POMS2 (Short Form) Fatigue - Inertia T score 5.Brief Job Stress Questionnaire 6.Chalder fatigue scale
Key secondary outcomes	1.IgA in feces 2.OSA Sleep Inventory 3.Fecal Questionnaire

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
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: 40 and over, below 60 2) Males and females with Japanese nationality 3) Profile of Mood States (POMS2) Short Form Fatigue - Inertia T Score: 60 and over 4) Daytime workers who are not primarily engaged in physical labor but are engaged in sales, clerical work, administrative work, etc. 5) Persons who wake up same time every morning 6) Scoring of Immunological Vigor (7 items): 10 to 18 7) Persons who are able to take 6 tablets/day for 8 weeks on the continuous basis
Key exclusion criteria	1) Currently in treatment with medication or seeing a doctor for treatment 2) A positive test result on hepatitis B 3) Allergic to food, medication, pollen, or with another type of allergic disease 4) Regular intake of medication with a possible influence on an immune function (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, anti-allergy drugs, lactobacillus preparation, etc.) 5) Vaccinated within the past 3 months or desired to be vaccinated during a study period 6) Current habit of smoking 7) Extreme faddiness 8) Extremely irregular lifestyle including an irregular eating pattern, a irregular sleep pattern, etc. 9) Presence or previous history of a mental disorder (depression, etc.) 10) Regular intake of any one of food (mushrooms, barley, seaweeds), health food products, and supplements with high content of beta-glucan 11) High alcohol intake (alcohol intake of 60 g and over per day) 12) Engaged in active sports resulted in shortness of breath, such as jogging, marathon, or soccer. 13) Currently participating another clinical study or participation in another clinical study within the past 3 months 14) Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	120

Research contact person
Name of lead principal investigator	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	matsuoka@huma-c.co.jp

Public contact
Name of contact person	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	matsuoka@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Group Holdings,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date	2017 Year 11 Month 16 Day
Date of closure to data entry	2017 Year 11 Month 18 Day
Date trial data considered complete	2017 Year 12 Month 04 Day
Date analysis concluded	2017 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 03 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032114