UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036773 |
|---|---|
| Receipt number | R000041876 |
| Scientific Title | Efficacy test of supplement containing plant extract |
| Date of disclosure of the study information | 2020/05/15 |
| Last modified on | 2020/05/07 11:55:20 |
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Basic information
Public title
Efficacy test of supplement containing plant extract
Acronym
Efficacy test of supplement containing plant extract
Scientific Title
Efficacy test of supplement containing plant extract
Scientific Title:Acronym
Efficacy test of supplement containing plant extract
Region
| Japan |
Condition
Condition
Healthy Japanese adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to verify the effects on body fat of test foods in adult men and women of BMI 25 and under 30 and abdominal visceral fat area (VFA) 80 cm^2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat percentage and change
Neutral fat and change
Key secondary outcomes
Weight and change
BMI and change
Waist circumference and change
Hip circumference and amount of change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of plant extract-containing food for 12 weeks
Interventions/Control_2
Intake of plant extract free food for 12 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Persons aged 20 to 65 years of age at the time of obtaining informed consent
2) A healthy person who is not currently treating any disease
3) Persons with BMI of 25.0 kg / m2 or more and less than 30.0 kg / m2 at screening 4) Persons with a VFA of 80 cm2 or more using a CT scanner system
5) Those who can visit the designated medical institution on the scheduled examination date
6) A person who agreed in writing after fully understanding the purpose and content of this study
Key exclusion criteria
1)Those who have difficulty participating in the study due to liver, kidney, heart disease, respi ratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes (according to the criteria establ ished by the Japan Diabetes Association), and o ther diseases
2) Person with a history of cardiovascular disease
3) Those who are taking glucose metabolism, lipid metabolism, blood pressure improvement drugs
4) Those who regularly use medicines and health foods / supplements (including foods for specified health, functional labeling foods and nutritionally functional foods) that may affect this study (but stop taking it at the time of obtaining consent) The person who can do it does not correspond)
5) Persons who have allergies related to the test food
6) Those who have experienced poor mood or physical condition by blood collection in the past
7) Those who donated more than 200 mL from the month before the start of the test to the start of the test
8) Those who are participating in other clinical trials or within 4 weeks after the trial
9) Alcoholic drinkers and excessive smokers
10) Eating habits are extremely irregular
11) Those who wish to become pregnant during the study period, pregnant women (including those who may be pregnant) or those who are lact ating
12) Those who can not agree with the purpose of the description of this exam that is conducted in advance
In addition, those who were judged inappropriate for this study by the study investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
RYUSENDO CO., LTD
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
RYUSENDO CO., LTD
Division name
Development Office
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
KYOWA TRIAL CO., LTD
Institute
Department
Personal name
Funding Source
Organization
RYUSENDO CO., LTD.
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
Akanuma Surgeon Board Ethics Review Committee
Address
Ishiyama 2-jo 6-chome 14-1, Minami-ku, Sapporo-shi, Hokkaido
Tel
011-591-1777
s-ito@kyowa-t.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
| 2020 | Year | 05 | Month | 15 | 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
https://www.ffhdj.com/index.php/ffhd/article/view/702
Number of participants that the trial has enrolled
44
Results
A significant difference was observed in the primary outcome.
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese adult
Participant flow
44 participants completed and 32 subjects were incorporated into the analyses.
Adverse events
No adverse effect reported
Outcome measures
Body fat percentage and changes
Triglycerides and changes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 07 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041876
