UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the antiobesity effect of a plant extractIngredient G-PX
Title of the study (Brief title)	Verification of the antiobesity effect of a plant extract
Region	Japan

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

Objectives
Narrative objectives1	To compare and investigate the antiobesity effect before and after the consumption of a test food, using placebo as the control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in the visceral fat area between before consumption of the test food and at the end of consumption
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	Prevention
Type of intervention	Food
Interventions/Control_1	once a day for 12weeks
Interventions/Control_2	Placebo capsule 10mg once a day for 12weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Men and women aged >= 20years (2)Those with BMI in the range>=25to<30 (3)Those who can visit the specified institution on the scheduled day of visit (4)Those who adequately understand the objective and details of this study, and give written informed consent
Key exclusion criteria	(1)Those who are receiving treatment at the time of participation in the study (2)Pregnant (or possibly pregnant) or lactating women (3)Those who have donated blood components or 200 mL of whole blood within 4 weeks prior to the consumption of the test food (4)Those who have donated 400 mL of whole blood within 16 weeks prior to the consumption of the test food (5)Those who have had >1,000 mL of blood collected within 48 weeks prior to the consumption of the test food (6)Those who are participating in another trial or study (7)Those who meet any of the following criteria: i.Those with heart, liver, or kidney disease (including complications of other diseases) ii.Those with a history of cardiovascular disease iii.Those with diabetes mellitus iv.Those who are being treated for or with a history of serious diseases including cancer and asthma (8)Those with a history of major surgery in the gastrointestinal regions, including gastrectomy, gastrointestinal suture, and intestinal resection (9)Those with severe food allergy (10)Those who routinely take supplements that contain the same components as the test food (11)Those judged inadequate to enroll in the study at the discretion of the principal investigator or subinvestigator
Target sample size	100

Research contact person
Name of lead principal investigator	Takashi Kuriki
Organization	Ezaki Glico Co., Ltd.,
Division name	Institute of Health Sciences
Address	4-6-5 Utajima, Nishi-Yodogawa, Osaka-shi Osaka-fu
TEL	+81-6-6477-8425
Email	kuriki-takashi@glico.co.jp

Public contact
Name of contact person	Ryou Kakutani
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Helth Sciences
Address	4-6-5, Utajima, Nishi-yodogawa, Osaka
TEL	06-6477-8362
Homepage URL
Email	kakutani-ryou@glico.co.jp

Sponsor
Institute	Ezaki Glico Co.,Ltd.,Institute of Health Sciences
Institute
Department

Funding Source
Organization	Glico Nutrition Co.,Ltd.
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	医療法人共創会AMC西梅田クリニック

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry	2016 Year 08 Month 10 Day
Date trial data considered complete	2016 Year 09 Month 10 Day
Date analysis concluded	2016 Year 09 Month 25 Day

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

Management information
Registered date	2016 Year 03 Month 18 Day
Last modified on	2016 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024475