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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023760
Receipt No. 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

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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
Email 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
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027360

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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