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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024748
Receipt No. 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

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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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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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