UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036773
Receipt No. 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 (Ver. 5)

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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
Email 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
Email m.takahashi@ryusendo.co.jp

Sponsor
Institute KYOWA TRIAL CO., LTD
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041876