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
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
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
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
