UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study-
Acronym	A study to evaluate the effects of functional food on body fat mass
Scientific Title	A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study-
Scientific Title:Acronym	A study to evaluate the effects of functional food on body fat mass
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and efficacy of intake of the test food for 12 weeks on body fat mass in in healthy adults classified as pre-obese or obese class I
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal visceral fat area
Key secondary outcomes	Body weight, BMI, body fat percentage, abdominal total fat area, abdominal subcutaneous fat area, body composition (In Body), circumference, questionnaire survey

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 5 tablets of the test food for 12 weeks
Interventions/Control_2	Intake 5 tablets of the 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females aged of 20-64 years at the date of informed consent 2) Subjects whose BMI 24 kg/m2 or more and less than 30 kg/m2 3) Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
Key exclusion criteria	1)Subjects who use pharmaceuticals affecting the study 2)Subjects who have a history of severe kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., and undergoing treatment for them (excluding transient treatment such as colds) 3)Subjects who cannot stop taking supplements and health foods (including foods for specified health use and foods with functional claims) that may affect something for the test in the study period 4)Subjects who declare some allergies to the components of the test food 5)Subjects who have a history of drug/alcohol dependence or a current medical history 6)Subjects who have metal by surgery and others in measurement areas for CT scan 7)Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators 8)Claustrophobic 9)Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period 10)Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past month from the date of consent, or who plan to participate in others 11)Subjects judged as unsuitable for this study by the principal investigator
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Sagami
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Doctor
Zip code	108-0075
Address	1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL	03-3452-3382
Email	shibaura@sempos.or.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	108-0023
Address	1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	NatureLab.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	Ethical Committee of Kobuna Orthopedics Clinic
Address	311-2, Gokammachi, Maebashi Shi, Gumma Ken, 371-0813, Japan
Tel	027-212-5608
Email	sagawa@mc-connect.co.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	一般財団法人船員保険会　品川シーズンテラス健診クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 21 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 11 Day
Date of IRB	2021 Year 05 Month 13 Day
Anticipated trial start date	2021 Year 07 Month 10 Day
Last follow-up date	2021 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 21 Day
Last modified on	2021 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051319