UMIN-CTR Clinical Trial

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