UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032321 |
|---|---|
| Receipt number | R000035696 |
| Scientific Title | The study of a long-term ingestion of a plant-deriverd processed product |
| Date of disclosure of the study information | 2018/04/19 |
| Last modified on | 2019/12/26 16:35:42 |
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Basic information
Public title
The study of a long-term ingestion of a plant-deriverd processed product
Acronym
The study of a plant-derivered processed product
Scientific Title
The study of a long-term ingestion of a plant-deriverd processed product
Scientific Title:Acronym
The study of a plant-derivered processed product
Region
| Japan |
Condition
Condition
Nothing(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a long-term ingestion of a plant-derived processed product
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
Body weight, Body Mass Index
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food (product code;T-001)
1-year repeated consumption
Dose of 1 serving per day
Body weight measurement every 1 or 2 month
Interventions/Control_2
Test food (product code;S-001)
1-year repeated consumption
Dose of 1 serving per day
Body weight measurement every 1 or 2 month
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, healthy adult aged from 20 to 60
2, get informed consent in written
Key exclusion criteria
1, difficult o participate the study due to
dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions
2, surgery for a disease or an injury 2 months prior to the study
3, treatment with medicine to improve glucose metabolism, fat metabolism, or blood presser
4, cat't maintain his/her habitual consumption of foods with health claim, supplement use or physical activity throughout the study periods including pre-treatment period.
5, experienced unpleasant feeling during blood drawing.
6, use of pacemaker, or metallic allergy and skin disease
7, weight change of 3kg and more within 1 month before the study
8, shift worker
9, allergies against any constituents in the test diet
10, potential to entry test of same test diet
11, disagree with explanation for study
12, judged to be inappropriate as subject by physician in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Saito |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL
03-5630-7456
saito.shinichiro@kao.com
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Yamanaka |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL
03-5630-7456
Homepage URL
yamanaka.nami2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.com
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
| 2018 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
68
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035696
