UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.
Title of the study (Brief title)	Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.
Region	Japan

Condition
Condition	obesity
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate safety and efficacy of a dietary supplement containing Irvingia gabonensis extract for weight-management.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is evaluation of safety as phase I trial. An evaluation of adverse events.
Key secondary outcomes	Efficacy for body composition as phase II study.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	An extract derived from Irvingia gabonensis is administered for 8 weeks.
Interventions/Control_2
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	- Age: more than or equal to 20 years at the time of providing informed consent - Individuals who have never experienced psychological and critical diseases. - Individuals who have the ability to provide written informed consent.
Key exclusion criteria	- Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc.) and who is taking any drugs. - Subjects judged to be inappropriate for the study by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Seika Kamohara MD, PhD
Organization	DHC Corporation
Division name	Division of Research Adviser
Address	Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL	0354423945
Email	kamohara-seika@umin.ac.jp

Public contact
Name of contact person	Seika Kamohara MD, PhD
Organization	DHC Corporation
Division name	Division of Research Adviser
Address	Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL	0354423945
Homepage URL
Email	kamohara-seika@umin.ac.jp

Sponsor
Institute	DHC Corporation
Institute
Department

Funding Source
Organization	DHC Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Suidobashi Medical Clinic
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	水道橋メディカルクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 03 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry	2015 Year 10 Month 01 Day
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	2014 Year 10 Month 27 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018043