UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of an excessive consumption of a grain-derived processed product A001.
Title of the study (Brief title)	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	Takahiro Ono
Organization	Medical Corporation Wakei-kai Medics Hongo Clinic
Division name	Director
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	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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