UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018506
Receipt number R000020542
Scientific Title Safety evaluation of an excessive consumption of a plant-derived processed product
Date of disclosure of the study information 2015/07/31
Last modified on 2019/07/26 11:10:15

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Basic information

Public title

Safety evaluation of an excessive consumption of a plant-derived processed product

Acronym

Safety evaluation a plant-derived processed product

Scientific Title

Safety evaluation of an excessive consumption of a plant-derived processed product

Scientific Title:Acronym

Safety evaluation a plant-derived processed product

Region

Japan


Condition

Condition

Nothing (healty subject)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of a plant-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)
physical examination
blood general analysis
biochemical test
urinalysis

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

Treatment

Type of intervention

Food

Interventions/Control_1

Control food (product code ; C-001)
3 times of serving size per day for 4 weeks

Interventions/Control_2

Test food (product code ; A-001)
3 times of serving size per day for 4 weeks

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1, BMI>=18.5 and <30 kg/m2
2, BMI>=20 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 of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions.
2, Person who takes medication for glucose or fat metabolism, or hypertension.
3, Person who was given surgery for a disease or an injury 2 months prior to the study.
4, Individual intakes supplements or the food for specific use of health authorized the government.
5, Person had allergy against any constituents in the test diet.
6, Person who is used to take test food.
7, Individual experienced unpleasant feeling during blood drawing.
8, Person who donated 200mL or more of blood within a month prior to the study.
9, Heavy smoker
10, Person who don't record of meal recoding for 9 days
11, Shift worker
12, Person who is planned long term business trip or travel of a domestic or foreign country in study priod
13, Person who can't accept to be accessed their medical records.
14, Person who have participated in other clinical studies.
15, Person who are expecting pregnancy or lactation period.
16, Person who are considered inappropriate by medical doctors.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yoshihisa
Middle name
Last name Katuragi

Organization

KAO CORPORATION

Division name

Health Care Food Research Labs

Zip code

131-8501

Address

2-1-3 Bunka Sumida-ku Tokyo

TEL

03-5630-7452

Email

katsuragi.yoshihisa@kao.co.jp


Public contact

Name of contact person

1st name Yuri
Middle name
Last name Agawa

Organization

QOLRD CORPORATION

Division name

CRO Department

Zip code

103-0027

Address

2-14-1 Nihonbashi Tyuo-ku Tokyo

TEL

03-6386-8809

Homepage URL


Email

y-agawa@qol-rd.co.jp


Sponsor or person

Institute

QOLRD CORPORATION

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

Hasuda ishinkai clinic IRB

Address

3-17 Honcho, Hasuda city, Saitama

Tel

048-764-6411

Email

hs_iji2@hasuda-issinkai.jp


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

蓮田一心会病院(埼玉県)、金沢文庫病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 31 Day


Related information

URL releasing protocol

http://www.lifescience.co.jp/yk/yk16/jun/ab4.html

Publication of results

Published


Result

URL related to results and publications

http://www.lifescience.co.jp/yk/yk16/jun/ab4.html

Number of participants that the trial has enrolled

60

Results

Excessive consumption of test diets was safe

Results date posted

2019 Year 07 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

healthy subjects

Participant flow

60 participants completed and 60 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

safety

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 06 Month 25 Day

Date of IRB

2015 Year 06 Month 25 Day

Anticipated trial start date

2015 Year 07 Month 31 Day

Last follow-up date

2015 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 31 Day

Last modified on

2019 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name