UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022477 |
|---|---|
| Receipt number | R000025745 |
| Scientific Title | Safety evaluation of an excessive consumption of a plant-derived product A-003 |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2019/08/27 08:47:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety evaluation of an excessive consumption of a plant-derived product A-003
Acronym
Safety evaluation of an excessive consumption of a plant-derived product
Scientific Title
Safety evaluation of an excessive consumption of a plant-derived product A-003
Scientific Title:Acronym
Safety evaluation of an excessive consumption of a plant-derived product
Region
| Japan |
Condition
Condition
Nothing (healthy 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)
Incidence of adverse effect
Key secondary outcomes
anthropometric parameters
blood hematology
blood biochemical test
urine test
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-003)
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, and 4 weeks.
Interventions/Control_2
Test food (product code; A-003)
5 times of effective dose size per day for 4 weeks, safety evaluations are performed at 0, 2, and 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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. BMI>=22.0 and <30 kg/m2
2. BMI>=20 and <65 years-old
3. Individual provides informed consent by a document.
Key exclusion criteria
1.Individual with liver, kidney and heart disease, or disorder of respiration, endocrine,metabolism, nervous system, consciousness, or diabetes, or other diseases.
2.Individual given surgery within 2 months before the final examination.
3.Medicine user for hyperglycaemia, lipidemia, or hypertension.
4.Individual intakes the food for specific use of health authorized the government and foods with function claims
5.Individual experienced unpleasant feeling by drawing blood in the past.
6.Individual donated 200 ml or more of blood within a month prior to the study.
7.Individual changed his/her weight
2 kg or more within 1month before the trial.
8.Night worker and shift worker.
9.Individual plans business trip for 10 consecutive days or more.
10.Individual can't intake test meal.
11.Individual had allergy against any constituents in the test meal.
12.Individual can not conform to control of alcohol(equivalent of 500 ml of beer per day).
13.Individual can not conform to record of "life daily"every day during the period of the test.
14.Individual can not conform to record of daily diet for 9 days(3 days x 3 times).
15.Individual cannot allow operator to consult his/her data of the past health check.
16.Individual have already participated other clinical trial and will participate.
17.Individual can not agree with preliminary explanation.
18.Pregnant women or breast-feeding women.
19.Individual who was judged ineligibles by clinician in this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Medical office
Zip code
061-1351
Address
3-1-15,Shima-matsuhigashimachi,Eniwa-shi,Hokkaido,Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Konagai |
Organization
New Drug Research Center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1,Toiso,Eniwa-shi,Hokkaido,Japan
TEL
0123-34-0412
Homepage URL
s-konagai@ndrcenter.co.jp
Sponsor or person
Institute
New Drug Research Center, Inc.
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
The Ethics Review Board of Miyawaki Orthopedic Hospital
Address
3-1-6 Ariake-cho, Eniwa city, Hokkaido
Tel
0123-33-4026
d-kameda@mediffom.co.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/44120/1763
Number of participants that the trial has enrolled
20
Results
No significant difference in the primary outcome
Results date posted
| 2019 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
20 participants completed and 20 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
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025745
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
