UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Title of the study (Brief title)	Dose-dependent anti-obesity effect of the plant extract in subjects with abdominal obesity
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the dose-dependent effect of the plant extract (four doses) on adiposity-related parameters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Visceral fat area at baseline, 8 and 12 weeks.
Key secondary outcomes	Body weight, body fat percentage, and waist circumference at baseline, 8 and 12 weeks.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects receive 3.2 g/day of placebo powder for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_2	Subjects receive 4.2 g/day of study treatment powder (containing 300 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_3	Subjects receive 5.7 g/day of study treatment powder (containing 413 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
Interventions/Control_4	Subjects receive 6.2 g/day of study treatment powder (containing 551 mg of the plant extract) for 12 weeks, by dissolving the powder in 350 mL of hot water and replacing their daily tea drink with it.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Visceral fat area not lower than 100 cm2
Key exclusion criteria	1) Smoker 2) Heavy user of alcohol (more than two drinks a day) 3) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 4) Taking drugs or functional food that may affect the trial 5) Participation in any clinical trial within 90 days of the commencement of the trial 6) In pregnancy or nursing a child 7) Cardiac, renal, and/or hepatic dysfunction 8) History of severe disease and/or major surgery
Target sample size	60

Research contact person
Name of lead principal investigator	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
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)

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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 14 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023315