UMIN-CTR Clinical Trial

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

Nothing(Healthy adults)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社TESホールディングス（東京都）

Date of disclosure of the study information

2016

Year

08

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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