UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029357 |
|---|---|
| Receipt number | R000033552 |
| Scientific Title | Safety evaluation of excessive intake of food containing HYA for healthy adults. |
| Date of disclosure of the study information | 2017/09/29 |
| Last modified on | 2017/12/25 11:32:20 |
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Basic information
Public title
Safety evaluation of excessive intake of food containing HYA for healthy adults.
Acronym
Safety evaluation of excessive intake of food containing HYA
Scientific Title
Safety evaluation of excessive intake of food containing HYA for healthy adults.
Scientific Title:Acronym
Safety evaluation of excessive intake of food containing HYA
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of food containing HYA, 5-fold quantity of recommended daily intake, for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine test
Blood pressure/pulsation
Weight/body mass index
Medical Interview
Adverse event
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
Consumption of food containing HYA for 5-fold Quantity of recommended daily intake, 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 69 years of age
(2) Subjects falling under any of the following
A. fasting blood glucose levels are less than 110 mg/dL or 2-hour glucose levels in 75 g OGTT are less than 140 mg/dL (about 10 subjects)
B. fasting blood glucose levels are ranged 110 to 125 mg/dL or 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL (about 10 subjects)
Key exclusion criteria
(1) Subjects who routinely use health food containing large amount of unsaturated fatty acids or health food for diet
(2) Subjects who constantly use oral medication and/or functional foods which may affecting serum lipid levels, lipid metabolism and/or glycometabolism
(3) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(4) Subjects having possibilities for emerging allergy related to the test food
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the current study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Yonejima |
Organization
NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Division name
Research and Development Division
Zip code
Address
35-3, Minamibiraki., Kamiueno-cho, Muko-shi Kyoto
TEL
075-921-5344
y.yonejima@nitto-ph.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Tsuji |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
NITTO PHARMACEUTICAL INDUSTRIES 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
| 2017 | Year | 09 | Month | 29 | 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 | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | 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
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033552
