UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.
Title of the study (Brief title)	Study for evaluating the safety of excessive intake of food originated from a microorganism
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of food originated from a microorganism.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Interview by physician 2. Height and body weight 3. Blood pressure and pulse 4. Hematological test 5. Blood biochemical analysis 6. Urine analysis 7. Subjective symptom and objective response 8. Adverse events
Key secondary outcomes

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. 5 portion of food per day for 4 weeks.
Interventions/Control_2	Placebo food, 5 portion of food per day for 4 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	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, when giving the informed consent. (2) 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 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 with excessive alcohol-drinking behaviors (Maximum daily quantity: Approximately 20 g of pure alcohol per day, for example, beer 1 bottle 500 mL, whiskey double 1 cup 60 mL, or wine approximately 1.5 cups 180 mL, respectively) . (4) Individuals who cannot stop drinking for two days until the screening and each checkup. (5) Individuals having food allergy. (6) Individuals who have a medical history of hay fever. (7) Individuals who have a medical history of diseases affecting digestion and absorption. (8) Individuals who have tendency to get diarrhea by eating dairy product. (9) Individuals who have a history of irritable bowel syndrome and Crohns disease. (10) Individuals who are judged as unsuitable for the study based on the results of blood test. (11) Individuals who have under treatment or a history of drug addiction and/or alcoholism. (12) Individuals who are participating or willing to participate in other clinical trials with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products. (13) Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. (14) Individuals who refuse to answer their biological sex. (15) Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods. (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	Satoru Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical Examination and Treatment Management Family
Address	The 5th floor of Shinagawa season terrace, 1-2-70 Konan, Minato-ku, Tokyo, Japan
TEL	03-3452-3381
Email	satoru_suzuki@sempos.or.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales Department
Address	The 7th floor of Shibaura omodaka building, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 25 Day
Anticipated trial start date	2017 Year 05 Month 16 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 05 Month 11 Day
Last modified on	2017 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031291