UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of safety evaluation of the yeast materials long-term ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study.
Acronym	Safety evaluation of long-term ingestion of the yeast materials in humans.
Scientific Title	A verification study of safety evaluation of the yeast materials long-term ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study.
Scientific Title:Acronym	Safety evaluation of long-term ingestion of the yeast materials in humans.
Region	Japan

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

Objectives
Narrative objectives1	Safety evaluation of 12 weeks consecutive ingestion of the recommended daily intake of the test food.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Physical examination 2. Urinalysis 3. Blood test * Assess these tests at screening and examination before consumption, at 4, 8 and 12 weeks after consumption and 4 weeks after consumption completed.
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	Intake of Food containing yeast-derived protein once a day for 12 weeks.
Interventions/Control_2	Intake of placebo without yeast-derived protein once a day for 12 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 from 20 to 65 years of age. 2)Subjects who are deagnosed as eligible to participate in the study by the physician.
Key exclusion criteria	1)A medical history of malignant tumor, heart failure or myocardial infarction. 2) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3) Subjects who currently taking medications (including herbal medicines) 4) Subjects who are allergic to medications and/or the test food related products. 5) Subjects who are pregnant, breast-feeding, or planning to become pregnant. 6) Subjects who are judged as ineligible to participate in the study by the physician.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
Zip code
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	075-394-8605
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Middle name Last name Utano Nakamura
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
Zip code
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	075-394-8605
Homepage URL
Email	u-nakamura@pharmafoods.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	FH17-001
Org. issuing International ID_1	Nihonbashi-egawa clinical research ethical review committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 10 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
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	Main results already published
Date of protocol fixation	2018 Year 06 Month 26 Day
Date of IRB	2018 Year 07 Month 13 Day
Anticipated trial start date	2018 Year 08 Month 10 Day
Last follow-up date	2019 Year 01 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	2018 Year 07 Month 25 Day
Last modified on	2021 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038208