UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000018506
Receipt No. 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 (Ver. 11)

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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
Institute QOLRD CORPORATION
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020542