UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023760 |
|---|---|
| Receipt number | R000027360 |
| Scientific Title | Safety evaluation of an excessive consumption of a grain-derived processed product A001. |
| Date of disclosure of the study information | 2016/08/26 |
| Last modified on | 2017/02/23 09:27:20 |
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Basic information
Public title
Safety evaluation of an excessive consumption of a grain-derived processed product A001.
Acronym
Safety evaluation of an excessive consumption of a grain-derived processed product A001.
Scientific Title
Safety evaluation of an excessive consumption of a grain-derived processed product A001.
Scientific Title:Acronym
Safety evaluation of an excessive consumption of a grain-derived processed product A001.
Region
| Japan |
Condition
Condition
Nothing(Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of a grain-derived processed product
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation (repeated ingestion for 4 weeks) at before and after 2 and 4 weeks ingestion.
anthropometric parameters
blood hematology
blood biochemical test
urine test
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
Control food (product code; P001)
3 times of effective dose per day for 4 weeks, safety evaluations were performed at 0, 2, and 4 wk points.
Interventions/Control_2
Test food (product code; A001)
3 times of serving size per day for 4 weeks, safety evaluations were performed at 0, 2, and 4 wk points.
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.BMI>=22.0 and < 30kg/m2
2.Man and Woman whose age is >=25 and <65 years-old.
3.Person who provides informed consent by a document.
Key exclusion criteria
1.Person who is difficult to participate the study due to dysfunctions liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions.
2.Person who was given surgery or medication treatment for a disease or an injury 2 months prior to the study.
3.Medicine user for hyperglycaemia, lipidemia, or hypertension.
4.Person who habitually takes the foods for specified health uses (FOSHU) or functional food. (Except for subjects who can stop consume them after informed consent).
5.Person who experienced unpleasant feeling during blood drawing.
6.Person who has donated over 200 mL of blood within the last one month prior to the current study.
7.Person whose weight changes more than 2 kg during past one year.
8.Person who is shift worker
9.Person who plan to go long term business trip or trip (more than 10 consecutive days) during current study.
10.Person who can't intake test meal.
11.Person who has possibility for allergic reaction to any constituents in the test meal.
12.The person who cannot observe a limit of the quantity of drinking (under 20 g/day alcohol)
13.Person who cannot input to 'life diary' (the intake situation, record of the physical condition) every day during the period of the test.
14.Person who can not input to a meal record for 9 days (3 days x 3 times)
15.Person who can't accept to access past medical chart.
16.Person who has participated in other clinical study or are planned to participate in other clinical study.
17.Person who can't agree current informed consent.
18.Woman who is pregnant, breast-feeding, or expecting pregnancy during the period of the test.
19.Person who is judged to be inappropriate for current study based on the medical chart by medical doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Ono |
Organization
Medical Corporation Wakei-kai Medics Hongo Clinic
Division name
Director
Zip code
Address
2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL
03-6801-9761
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
株式会社TESホールディングス（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 26 | 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 | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | 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
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027360
