UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029058 |
|---|---|
| Receipt number | R000033235 |
| Scientific Title | Safety evaluation of excessive intake of yogurt , in adult men and women |
| Date of disclosure of the study information | 2018/11/18 |
| Last modified on | 2019/11/27 16:42:56 |
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Basic information
Public title
Safety evaluation of excessive intake of yogurt , in adult men and women
Acronym
Safety evaluation of excessive intake of yogurt , in adult men and women
Scientific Title
Safety evaluation of excessive intake of yogurt , in adult men and women
Scientific Title:Acronym
Safety evaluation of excessive intake of yogurt , in adult men and women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of yogurt drink containing lactic acid bacteria LH strain, 3-fold quantity of recommended daily intake.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test product for 4 weeks
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Subjects aged from 20 to 64 years old
(2)Subjects about 10 people with negative for specific IgE(RAST)against house dust and mite.
(3)Subjects about 10 people with discomfort of eyes and nose(sneeze, runny nose, nasal) and positive for specific IgE (RAST) against house dust and mite.
Key exclusion criteria
(1)Subjects visiting the hospital for discomfort of eyes and nose or medicines affecting the test result
(2)Subjects who have history of regular visits of otorhinolaryngology or planned to clinic visits
(3)Subjects with acute rhinitis, sinusitis or hypertrophic rhinitis
(4)Subjects with bronchial asthma
(5)Subjects with allergies to the test food in the study
(6)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function
(7)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9)Subjects who have participated in other clinical studies
(10)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(11)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(12)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujta |
Organization
MEGMILK SNOW BRAND Co.,Ltd.
Division name
Milk Science Research Institute Food Function Laboratory
Zip code
Address
1-1-2 Minamidai,Kawagoe,Saitama, Japan
TEL
049-242-8111
tfujita@meg-snow.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Goto |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co.,Ltd.
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
| 2018 | Year | 11 | Month | 18 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033235
