UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015534
Receipt number R000018043
Scientific Title Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.
Date of disclosure of the study information 2014/10/28
Last modified on 2018/05/01 07:49:40

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Basic information

Public title

Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.

Acronym

Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.

Scientific Title

Safety and efficacy of a dietary supplement containing Irvingia gabonensis extract.

Scientific Title:Acronym

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

1st name
Middle name
Last name Seika Kamohara MD, PhD

Organization

DHC Corporation

Division name

Division of Research Adviser

Zip code


Address

Minami-azabu 2-7-1, Minato-ku, Tokyo

TEL

0354423945

Email

kamohara-seika@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seika Kamohara MD, PhD

Organization

DHC Corporation

Division name

Division of Research Adviser

Zip code


Address

Minami-azabu 2-7-1, Minato-ku, Tokyo

TEL

0354423945

Homepage URL


Email

kamohara-seika@umin.ac.jp


Sponsor or person

Institute

DHC Corporation

Institute

Department

Personal name



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)



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

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


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

2014 Year 10 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018043


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name