UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023491 |
|---|---|
| Receipt number | 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 00:03:31 |
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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
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
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Fukuhara Clinic
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
Miyawaki Orthopedic Clinic IRB
Address
3-1-6, Ariakechou, Eniwa,Hokkaido, Japan
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027060
