UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of test food on body fat-reducing.
Acronym	A study to evaluate the effect of test food on body fat-reducing.
Scientific Title	A study to evaluate the effect of test food on body fat-reducing.
Scientific Title:Acronym	A study to evaluate the effect of test food on body fat-reducing.
Region	Japan

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

Objectives
Narrative objectives1	To investigate effects of a test food on the reduction of body fat.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body fat area determined by CT
Key secondary outcomes	Body weight, body mass index, waist circumference, body fat percentage

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	Daily intakes of a test food for 12 weeks
Interventions/Control_2	Daily intakes of a placebo food 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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects whose BMI values are over 25 but less than 30.
Key exclusion criteria	1.Individuals being patient or have a history of serious disease of liver, kidney, heart, internal organs and diabetes. 2.Individuals who cannot quit to intake of supplements and/or medicine which may affect the results of measurement. 3.Individuals who are allergic to the test foods 4.Individuals who are pregnant, lactation, and planning to be pregnant 5.Subjects who drink alcohol a lot (60 g and more of alcohol a day on average) and/or smoke a lot (20 and more cigarettes a day on average) 6.Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift 7.Individuals who are judged as ineligible to participate this trial by physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Ishikawa
Organization	Medical Corporation Shoureikan Sinsapporo Seiryo Hospital
Division name	Internal Medicine
Zip code	004-0004
Address	4-2-1-30 , Atsubetsuhigashi, Atsubetsu-ku, Sapporo, Hokkaido
TEL	011-898-2151
Email	Ishikawa_seiryo@yahoo.co.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Takehara
Organization	Clinical Support Corporation Co., Ltd
Division name	PI-Food Service Division
Zip code	060-0061
Address	4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	Medical Corporation Shoureikan Sinsapporo Seiryo Hospital
Institute
Department

Funding Source
Organization	Asahi Group Holdings, 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	Medical Corporation Hokubukai Utsukushigaoka Hospital institutional review board
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel	001-882-0111
Email	matsuda@ughp-cpc.jp

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 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2076-2607/8/2/304
Number of participants that the trial has enrolled	169
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 06 Month 28 Day
Date of IRB	2018 Year 06 Month 28 Day
Anticipated trial start date	2018 Year 08 Month 29 Day
Last follow-up date	2019 Year 04 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 08 Month 27 Day
Last modified on	2020 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038654