UMIN-CTR Clinical Trial

Basic information
Public title	Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage - Randomized placebo-controlled double-blind parallel group comparison study -
Acronym	Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage
Scientific Title	Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage - Randomized placebo-controlled double-blind parallel group comparison study -
Scientific Title:Acronym	Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Clinical immunology Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of decreasing VFA (Visceral fat area) level by ingestion of the the food containing indigestible dextrin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy Visceral fat area
Key secondary outcomes	Efficacy Total fat area, subcutaneous fat area, body weight, BMI, Triglycerides, glycometabolism relation items Safety Side effect incidence,Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food(350mL)of 3 bottles of test beverage per day for 12 weeks
Interventions/Control_2	Intake of placebo food(350mL)of 3 bottles of test beverage per day for 12 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1 Males and females equal to or more than 20 years and less than 65 years old 2 Subjects with equal to or more than 23 and less than 30 kg/m^2 of BMI at the 1st screening test
Key exclusion criteria	1 Subjects who received medication treatment or surgery due to serious illness or injury within 1 months from the start of this study 2 Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 3 Subjects who medicine for glycometabolism, lipidmetabolism, or reducing high blood pressure 4 Subjects who regularly use over-the-counter medicine, health foods, supplements which are suggested causal relationship from the screening test 5 Pregnant and lactating female, or who wish to get pregnant during the study period 6 Heavy drinkers 7 Individual donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study 8 Subjects who are planned to change their life style or maitain irregular life during study period 9 Subjects who cannot follow test sample intake condition by the protocol 10 Subjects already participating in other clinical trials, subjects planning to participate during this examination period 11 Subjects who are ineligible due to physician's judgment
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyohisa Kaneko
Organization	Coca-Cola (Japan) Company, limited
Division name	Academic Director
Zip code
Address	6-3,Shibuya,4-chome,shibuyaku,Tokyo,Japan
TEL	03-5466-8000
Email	kkaneko@coca-cola.com

Public contact
Name of contact person	1st name Middle name Last name Yoshitaka Hatakeyama
Organization	New Drug Research Center, Inc.
Division name	Clinical Research Dept.
Zip code
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	y-hatakeyama@ndrcenter.co.jp

Sponsor
Institute	Coca-Cola (Japan) Company, limited Matsutani Chemical Industry co.,ltd
Institute
Department

Funding Source
Organization	Coca-Cola (Japan) Company, limited Matsutani Chemical Industry co.,ltd
Organization
Division
Category of Funding Organization	Profit organization
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 05 Month 08 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 02 Month 07 Day
Date of IRB	2018 Year 02 Month 06 Day
Anticipated trial start date	2018 Year 04 Month 16 Day
Last follow-up date	2018 Year 08 Month 25 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 05 Month 08 Day
Last modified on	2019 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037077