UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021715 |
|---|---|
| Receipt number | R000025053 |
| Scientific Title | A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverages containing plant extract (Ex.no. H24-0125) |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2019/09/13 19:22:48 |
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Basic information
Public title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverages containing plant extract (Ex.no. H24-0125)
Acronym
A clinical trial to investigate the effect of the foods containing plant extract
Scientific Title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverages containing plant extract (Ex.no. H24-0125)
Scientific Title:Acronym
A clinical trial to investigate the effect of the foods containing plant extract
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on obesity of 12 week-ingestion of the beverages containing plant extract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Total fat area, subcutaneous fat area, body weight, BMI, body fat, free fat mass, waist circumference, hip circumference, blood pressure, blood lipids related parameters, blood glucose related parameters, metabolic syndrome factors, liver function, inflammation related parameters
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
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Beverage containing plant extract for 12 weeks
Interventions/Control_2
Beverage without plant extract 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females equal to or more than 25 and less than 35 of BMI
Key exclusion criteria
1) Subjects consuming foods enriched with polyphenols
2) Subjects with cold before the study
3) Subjects with a history of allergy or might be liable to allergy related to the study
4) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system
5) Subjects who are ineligible due to physician's judgment
6) Subjects who participate in other clinical trials
7) Subjects who plan to become pregnant, who are during pregnancy, or who are nursing
8) Subjects who are ineligible due to life-style questionnaire
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchida |
Organization
Yokohama Tsuchida Medical Clinic
Division name
Doctor
Zip code
Address
1-7-10, Mori, Isogo-ku Yokohama city, Kanagawa, Japan
TEL
045-752-6111
t_tsuchida@drt-cl.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Yoneda |
Organization
QOL RD Co.,Ltd.
Division name
CRO Department Food Division.
Zip code
Address
2-14-1,Nihonbashi,Chuo-Ku,Tokyo,Japan
TEL
03-6386-8809
Homepage URL
s-yoneda@qol-rd.co.jp
Sponsor or person
Institute
QOL RD Co.,Ltd.
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
Address
Tel
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
よこはま土田メディカルクリニック、上尾甦生病院、石黒クリニック、亀戸南口クリニック、児玉中央病院、桜ヶ丘中央病院、白岡中央総合病院、笛吹中央病院、双葉クリニック、みずの内科クリニック、ゆきクリニック、吉川中央総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
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
| 2012 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025053
