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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035316
Receipt No. R000040207
Scientific Title A verification study of safety evaluation of excessive ingestion of the yeast materials in humans: a randomized, double-blind, placebo-controlled, parallel study.
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/19

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Basic information
Public title A verification study of safety evaluation of excessive ingestion of the yeast materials in humans: a randomized, double-blind, placebo-controlled, parallel study.
Acronym Safety evaluation of excess ingestion of the yeast in humans.
Scientific Title A verification study of safety evaluation of excessive ingestion of the yeast materials in humans: a randomized, double-blind, placebo-controlled, parallel study.
Scientific Title:Acronym Safety evaluation of excess ingestion of the yeast 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 more than 5 times amount 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 2 and 4 weeks after consumption and 2 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 extracts once a day for 4 weeks.
Interventions/Control_2 Intake of placebo without yeast extracts once a 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 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
Last 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
1st 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 19-PFI-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
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 19 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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