UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary study on the effect of functional food on body fat in human
Acronym	Preliminary study on the effect of functional food on body fat in human
Scientific Title	Preliminary study on the effect of functional food on body fat in human
Scientific Title:Acronym	Preliminary study on the effect of functional food on body fat in human
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect and safety of functional food 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

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Functional food(low dose), 12 weeks
Interventions/Control_2	Functional food(high dose), 12 weeks
Interventions/Control_3	Food without functional food, 12 weeks
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) Subject who is 20 years of age or older. 2) Subject, 23 kg/m2 <= BMI < 30 kg/m2. 3) Subject who is able to give written informed consent before the study.
Key exclusion criteria	(1)Subjects who are with treatment. (2)Subjects who are with history of gastrointestinal surgery. (3)Subjects who are attending other studies or attended other studies within the past 4 weeks. (4)Subjects who are; (a)With present heart disorder, liver disorder, or kidney disorder, (b)With history of cardiac disorder, (c)With diabetes mellitus, or (d)With allergy to the study foods. (5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test. (6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Nonaka
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0587
Email	Yuji_Nonaka@suntory.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kenji Yamamoto
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0594
Homepage URL
Email	K_Yamamoto@suntory.co.jp

Sponsor
Institute	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 24 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	2018 Year 07 Month 11 Day
Date of IRB	2018 Year 07 Month 11 Day
Anticipated trial start date	2018 Year 07 Month 25 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 18 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038119