UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass - Randomized placebo-controlled double-blind parallel group comparison study -
Acronym	A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass
Scientific Title	A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass - Randomized placebo-controlled double-blind parallel group comparison study -
Scientific Title:Acronym	A study to evaluate the effects of foods containing plant-derived ingredients 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 the test food on body fat mass including visceral fat during 12-week supplementation in healthy adult men and women 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 total fat area, BMI
Key secondary outcomes	body weight, body fat percentage, abdominal visceral fat area, abdominal subcutaneous fat area, waist circumference, hip circumference, W/H ratio, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fasting blood glucose, HbA1c

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take one capsule (680 mg) of the test food orally at dinner for 12 weeks
Interventions/Control_2	Take one capsule (680 mg) of the placebo food orally at dinner 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) Japanese males and females aged of 20-64 years at the date of the informed consent 2) Subjects whose BMI values are 27.0 or more and less than 32.0 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 regularly use pharmaceuticals 2) 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 3) 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) 4) Subjects who declare some allergies to the components of the test product 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 and dual scan 7) Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators 8) Claustrophobic 9) Subjects who plan to travel overseas or have a long business trip during this study period 10) Subjects who cannot take the test food as instructed 11) Subjects who cannot maintain daily living habits, such as shift workers and late-night workers 12) Smokers exceeding 20 cigarettes per day, subjects who regularly take more than 40 g per day of alcohol 13) Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period 14) 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 15) Subjects judged as unsuitable for this study by the principal investigator
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Iwao Middle name Last name Funahashi
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Zip code	107-6028
Address	1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL	050-3133-6397
Email	Iwao.Funahashi@kaneka.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO CORPORATION
Division name	Department of Facility Management
Zip code	105-0023
Address	1-9-7, Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO CORPORATION
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
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 Nihonbashi Cardiology Clinic
Address	13-4, Nihonbashi Kodenmacho, Chuo-ku, Tokyo, Japan
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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 05 Month 23 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	2019 Year 12 Month 19 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 02 Month 26 Day
Last follow-up date	2020 Year 06 Month 21 Day
Date of closure to data entry	2020 Year 08 Month 11 Day
Date trial data considered complete	2020 Year 11 Month 04 Day
Date analysis concluded	2021 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 24 Day
Last modified on	2021 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044756