UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat - Randomized placebo-controlled double-blind parallel group comparison study-
Acronym	A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat
Scientific Title	A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat - 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 the reduction of visceral fat and body fat
Region	Japan

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

Objectives
Narrative objectives1	To evaluate for reduction of visceral fat / body fat and for safety when supplementation with food containing ingredients of plant origin for 12 weeks for healthy adult men and women with BMI of 23.0 or more and less than 30.0 kg/m2
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal visceral fat area, body fat mass
Key secondary outcomes	Abdominal subcutaneous fat area, abdominal total fat area, waist circumference, hip circumference, W/H ratio, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, blood pressures (systolic and diastolic), fasting blood glucose, insulin, 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. 2)Subjects whose BMI values are 23.0 or more and less than 30.0. 3)Subjects who can visit the hospital/clinic on the scheduled visit date 4)Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Key exclusion criteria	1)Subjects who are under treatment or have a history of serious liver damage/disease, kidney disease, heart disease, lung disease, gastrointestinal disease (including gastrectomy), other severe disorders, or diabetes 2)Subjects who are under treatment (Excluding transient treatment such as common cold) 3)Subjects who cannot maintain their own life-style 4)Subjects who plan to travel overseas or have a long business trip during this study period 5)Subjects who are shift workers or graveyard shift workers 6)Subjects who use oral medication or supplements which may affect this study 7)Subjects drink alcohol over 1,000mL in terms of beer (= 40 mL of pure alcohol) per day 8)Subjects smoke over average 20 cigarettes per day 9)Subjects who are pregnant, lactation, or planning to become pregnant 10)Subjects who are sensitive to test product or other foods, and medical products. 11)Subjects who cannot take the test food as instructed 12)Subjects who donated blood component or more than 200 mL of whole blood from the last one month just before the start of the study 13)Subjects who have experienced sickness due to blood collection 14)Subjects in constipation (frequency of defecation twice or less a week, feces is hard, difficulty of defecation, feeling of remaining feces) 15)Subjects who participated in other clinical studies in the past 3 months 16)Subjects who have some metal inside the body 17)Subjects judged as unsuitable for this study by the principal investigator
Target sample size	180

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 Soichi Middle name Last name Yoneda
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Zip code	103-0027
Address	2-14-1, Nihonbashi, Chuo-ku, Tokyo,
TEL	03-6386-8809
Homepage URL
Email	s-yoneda@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
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	Kanazawabunko Hospital,IRB
Address	2-6-22,Kamariyahigashi,Kanazawaku,Ykohamashi,Kanagawa,Japan
Tel	045-785-3311
Email	watanabe@kanabun-hp.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	金内メディカルクリニック（東京都）、上尾中央第二病院（埼玉県）、笛吹中央病院（山梨県）、武蔵境クリニック（東京都）、久野マインズタワークリニック（東京都）、戸田中央総合病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2020 Year 05 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	200
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 09 Month 11 Day
Date of IRB	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 09 Month 27 Day
Last follow-up date	2019 Year 06 Month 30 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 09 Month 26 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039086