UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effects of ingestion of food constituents derived from microorganism on health and work performance of office workers.
Acronym	A study for the effects of food constituents derived from microorganism on health and work performance.
Scientific Title	A study for the effects of ingestion of food constituents derived from microorganism on health and work performance of office workers.
Scientific Title:Acronym	A study for the effects of food constituents derived from microorganism on health and work performance.
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ingestion food constituents derived from microorganism on health and work performance of office workers during winter.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Health and work performance questionnaire
Key secondary outcomes	Mood, physical condition and skin condition questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of food constituents derived from microorganism
Interventions/Control_2	Non-ingestion of food constituents derived from microorganism
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) Males and females aged from 20 to less than 65 years old. (2)Individuals who work inside the office. (3)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria	(1)Individuals who have or had a serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (2)Individuals who have chronic diseases and use medicines continuously. (3)Individuals who declare the allergy symptoms against test food. (4)Individuals who have tendency to get diarrhea by eating test food. (5)Individuals who are participating or willing to participate in other clinical trials of food, pharmaceutical or cosmetic products. (6)Individuals who are pregnant, planning to be pregnant in test period or breastfeeding. (7)Individuals who are judged as unsuitable for the study based on the results of pre-questionnaire. (8)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Ryohei Middle name Last name Shiraoka
Organization	Medical fitness laboratory
Division name	None
Zip code	1060032
Address	Sumitomo Fudosan Roppongi Building, 7-18-18, Roppongi, Minato, Tokyo, Japan
TEL	03-6671-9103
Email	mfl-info@medicalfitness.co.jp

Public contact
1st name of contact person	1st name Mihoko Middle name Last name Takuma
Organization	Yahoo Japan Corporation
Division name	Good conditioning division
Zip code	1020094
Address	Kioi Tower, Tokyo Garden Terrace Kioicho, 1-3 Kioicho, Chiyoda, Tokyo, Japan
TEL	03-6898-7145
Homepage URL
Email	mtakuma@yahoo-corp.jp

Sponsor
Institute	Yahoo Japan Corporation
Institute
Department

Funding Source
Organization	Yahoo Japan Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kirin Company, Limited
Name of secondary funder(s)	Kirin Company, Limited

IRB Contact (For public release)
Organization	Shiba Palace Clinic Research Ethics Committee
Address	Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, MInato-ku, Tokyo, Japan
Tel	03-5408-1599
Email	jimukyoku@mail.souken-r.com

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 11 Month 13 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	226
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	2017 Year 10 Month 27 Day
Date of IRB	2017 Year 10 Month 26 Day
Anticipated trial start date	2017 Year 11 Month 16 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2019 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034214