UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024748 |
|---|---|
| Receipt number | R000028384 |
| Scientific Title | Study of the safety of excessive intake of dietary dried yeast. |
| Date of disclosure of the study information | 2016/11/09 |
| Last modified on | 2017/05/16 14:53:49 |
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Basic information
Public title
Study of the safety of excessive intake of dietary dried yeast.
Acronym
Safety of dried yeast
Scientific Title
Study of the safety of excessive intake of dietary dried yeast.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Naoyuki Kamatani |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Doctors' office
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
kamatani@msb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Suzuki |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Division for Volunteer Control
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
Homepage URL
m-suzuki@tsukuba-icp.jp
Sponsor or person
Institute
Tsukuba International Clinical Pharmacology Clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 10 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028384
| 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 |
