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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021715
Receipt No. 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

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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
Email 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
Email s-yoneda@qol-rd.co.jp

Sponsor
Institute QOL RD Co.,Ltd.
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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