UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023491
Receipt No. R000027060
Scientific Title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the beverage containing plant extracts
Date of disclosure of the study information 2017/09/30
Last modified on 2020/04/01 (Ver. 7)

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Basic information
Public title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the beverage containing plant extracts
Acronym A clinical study to investigate the effect of the beverage containing plant extracts
Scientific Title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the beverage containing plant extracts
Scientific Title:Acronym A clinical study to investigate the effect of the beverage containing plant extracts
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of decreasing VFA (Visceral fat area) level by ingestion of the beverage containing plant extracts
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area, at 8 and 12 weeks after intake
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 The beverage containing plant extract, 12 weeks
Interventions/Control_2 The beverage non-containing plant extract, 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Males and females equal to or more than 20 years and less than 65 years of age
2.Healthy males and females with no treatment
3.Subjects equal to or more than 25 and less than 30 kg/m^2 of BMI at the pre-study
4.VFA level is above 80 cm^2
5.Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria 1.Subjects who have marked impairment of liver, kidney, heart, lung, endocrine, metabolism, nerve, or consciousness, or have DM
2.Subjects who have historical disease of circulatory system disease
3.Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure
4.Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them
5.Subjects who have allergy related to the test foods
6.Subjects who feel bad mood by blood collection in past
7.Subjects who donated 200 mL or more of blood within a month prior to the study.
8.Subjects who participate in other clinical trials within the last 4 weeks prior to the current study
9.Heavy dinkers or heavy smokers
10.Subjects whose eating habits are extremely irregular
11.Pregnant and lactating female, or who wish to get pregnant during the study period.
12.Subjects who can not agree with preliminary explanation.
13.Subjects who are ineligible due to physician's judgment.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Ikuo
Middle name
Last name Fukuhara
Organization Fukuhara Clinic
Division name Director
Zip code 061-1351
Address 3-1-15 Shima-matsuhigashi machi, Eniwa-shi, Hokkaido, Japan
TEL 0123-36-8029
Email i-feniwa@gray.plala.or.jp

Public contact
Name of contact person
1st name Shimpei
Middle name
Last name Tomita
Organization New drug research center, Inc.
Division name Clinical Research Dept.
Zip code 061-1405
Address 452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute Fukuhara Clinic
Institute
Department

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 Miyawaki Orthopedic Clinic IRB
Address 3-1-6, Ariakechou, Eniwa,Hokkaido, Japan
Tel 0123-33-4026
Email 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
2017 Year 09 Month 30 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 works in progress,http://www.pieronline.jp/content/article/0386-3603/46080/1383
Number of participants that the trial has enrolled 150
Results 
There was a significant difference in primary outcome
Results date posted
2020 Year 03 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
overweight
Participant flow 
144 participants completed and 150 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
visceral fat area
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 29 Day
Date of IRB
2016 Year 06 Month 29 Day
Anticipated trial start date
2016 Year 08 Month 05 Day
Last follow-up date
2017 Year 12 Month 25 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 08 Month 04 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027060