UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035316 |
|---|---|
| Receipt number | 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 | 2020/03/05 18:41:34 |
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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
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
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
u-nakamura@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
