UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial.
Title of the study (Brief title)	A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of oral intake of food originated from a microorganism on fatigue and immune functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fatigue and stress indices (subjective indices)
Key secondary outcomes	Fatigue and stress indices (objective indices), immune indices (subjective indices)

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	Food originated from a microorganism, 1 portion of food per day for 14 days.
Interventions/Control_2	Placebo food, 1 portion of food per day for 14 days.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Healthy individuals aged more than 18 years old, when giving the informed consent. 2)Individuals who are received enough explanation of the purpose and the details of this study, who decided to attend this study with their own will, who have ability of agreement, and who submitted the informed consents in writing.
Key exclusion criteria	1)Individuals who have a medical history of 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 need the application of medicine containing steroids. 4)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody. 5)Individuals who cannot stop eating foods containing ingredients similar to test foods. 6)Individuals who cannot stop eating functional foods which may affect immune functions. 7)Individuals with excessive alcohol-drinking behaviors. 8)Individuals who cannot stop drinking for 2 days before the days of checkup. 9)Individuals who have a medical history of diseases affecting digestion and absorption. 10)Individuals who have a history of inflammatory bowel disease and irritable bowel syndrome. 11)Individuals who are judged as unsuitable for this study based on the results of blood test. 12)Individuals who have under treatment or a history of drug addiction and/or alcoholism. 13)Individuals who are participating or willing to participate in other clinical trials. 14)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods. 15)Individuals who cannot sleep at night due to the irregular work-shift or other reasons. 16)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Kosuke Fukao
Organization	Juntendo University School of Health and Sports Science
Division name	Department of Sports Medicine (internal medicine)
Address	1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL	0476-98-1001
Email	fukao777@juntendo.ac.jp

Public contact
Name of contact person	Kosuke Fukao
Organization	Juntendo University School of Health and Sports Science
Division name	Department of Sports Medicine (internal medicine)
Address	1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL	0476-98-1001
Homepage URL
Email	fukao777@juntendo.ac.jp

Sponsor
Institute	Department of Sports Medicine (internal medicine), Juntendo University School of Health and Sports Science
Institute
Department

Funding Source
Organization	Kirin Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	順天堂大学スポーツ健康科学部／Juntendo University School of Health and Sports Science

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 02 Day
Anticipated trial start date	2017 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2017 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032868