UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of anti-obesity effects of the test food
Acronym	A verification study of anti-obesity effects of the test food
Scientific Title	A verification study of anti-obesity effects of the test food: an open-label trial
Scientific Title:Acronym	A verification study of anti-obesity effects of the test food
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the anti-obesity effects of consumption of the test food for 8 weeks in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The visceral fat area * Assess these by X-ray CT in a cross section of the umbilical region. * Assess the measured value at screening (before consumption) and at 8 weeks after consumption or calculate the amount of change.
Key secondary outcomes	1. Total fat area 2. Subcutaneous fat area 3. Blood adiponectin level 4. Blood triglyceride level 5. Body weight 6. Body mass index 7. Body fat percentage 8. Abdominal circumference 9. Subjective symptoms (the Likert scale) *1, 2 Assess these by X-ray CT in a cross section of the umbilical region. *1-9 Assess the measured value at screening (before consumption) and at 4 and 8 weeks after consumption or calculate the amount of change.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test food: Test tablets Administration: Take 3 tablets once a day with water and 30 minutes before lunch or dinner without chewing. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Japanese adult subjects who are between 25 kg/m2 or more and less than 30 kg/m2 in BMI 2. Subjects who are judged as eligible to participate in the study by the physician 3. Meeting the 1st and 2nd criteria requirements, subjects whose visceral fat area in a cross section of the umbilical region, assessed by X-ray CT, are less than 100 cm2 4. Meeting the 1st to 3rd criteria requirements, subjects whose visceral fat area in a cross section of the umbilical region, assessed by X-ray CT, are relatively large
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who receive hormonal therapy 5. Subjects who are planning to undergo a surgical operation within two weeks from the date of finish of the intervention period 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 7. Subjects who have habits of excessive exercise 8. Subjects who are currently taking medications (including herbal medicines) and supplements. Particularly taking an antidiabetic drug in daily. 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	NAGASE BeautyCare Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 17 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	11
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 05 Month 13 Day
Date of IRB	2019 Year 05 Month 13 Day
Anticipated trial start date	2019 Year 05 Month 18 Day
Last follow-up date	2019 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 16 Day
Last modified on	2020 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041892