UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the safety of excessive intake of dietary dried yeast.
Title of the study (Brief title)	Safety of dried yeast
Region	Japan

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

Objectives
Narrative objectives1	Examine the safety of excessive intake of dietary dried yeast product by Japanese healthy males and females.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of biochemical, hematological and urine tests between the time of screening and 4 weeks after the intake of the test food
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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral administration of dietary dried yeast product (containing 300 mg dietary dried yeast per capsule) 5 capsules once a day for 28 days
Interventions/Control_2	Oral administration of placebo product (containing no dietary dried yeast) 5 capsules once a day for 28 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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Japanese adult males and females 2. Age of 20 years or older and 70 years or younger 3. Subject with the ability to express his or her consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his or her consent to participate in the present clinical study.
Key exclusion criteria	1. Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function. 2. Subject who has or had hypersensitivity or idiosyncracy (allergy) to sake lees, drug or food. 3. Subject who is unable to maintain the life style stable during the study period. 4. Female who is either pregnant, feeding a baby or wants to have a baby during the study period. 5. Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of test food in this study. 6. Subject who plans to take other drugs (including herbs) or supplements before the end of the present study. 7.Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Naoyuki Kamatani
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Doctors' office
Address	1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL	029-839-1150
Email	kamatani@msb.biglobe.ne.jp

Public contact
Name of contact person	Masaki Suzuki
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Division for Volunteer Control
Address	1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL	029-839-1150
Homepage URL
Email	m-suzuki@tsukuba-icp.jp

Sponsor
Institute	Tsukuba International Clinical Pharmacology Clinic
Institute
Department

Funding Source
Organization	Mitsubishi Gas Chemical Co.
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	2016 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 24 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry	2017 Year 05 Month 10 Day
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	2016 Year 11 Month 08 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028384