UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study on the effect of the fish-derived component containing beverages on body fat in human
Title of the study (Brief title)	Preliminary study on the effect of the fish-derived component containing beverages on body fat in human
Region	Japan

Condition
Condition	obesity
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect and safety of the fish-derived component containing beverages on body fat in human.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal total fat area
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Fish-derived component containing beverage (low dose), 12 Weeks
Interventions/Control_2	Fish-derived component containing beverage (high dose), 12 Weeks
Interventions/Control_3	No fish-derived component containing beverage, 12 Weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subject who is 20 years of age or older. 2) Subject, 25 kg/m2 <= BMI < 30 kg/m2. 3) Subject who is able to give written informed consent before the study.
Key exclusion criteria	1) Subject receiving continuous medical treatment. 2) Subject with present disease such as liver disorder, kidney disorder, cardiac affection, diabetes mellitus. 3) Subject taking medication or functional foods, influencing the result of this study, such as medicine, food for specified health use, food with function claims supplement, diet food. 4) Subject with drug or food allergy 5) Female subject in pregnancy, lactation or intending to become pregnant during the study. 6) Subject deemed unsuitable by the investigator.
Target sample size	120

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0460
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Kayo Saito
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0527
Homepage URL
Email	Kayo_Saito@suntory.co.jp

Sponsor
Institute	QOL RD Co.,Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Suntory Beverage & Food Limited
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 21 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 07 Month 13 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021166