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 consumption of proteoglycan: An open-label trial
Scientific Title:Acronym	A verification study of anti-obesity effects of the consumption of proteoglycan
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 effect of anti-obesity effects of the consumption of the test food for four weeks in healthy Japanese adult subjects whose body mass index (BMI) is relatively high.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Body fat percentage * Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change.
Key secondary outcomes	1. Body weight 2. Body Mass Index 3. Muscle mass 4. Lean body mass 5. Abdominal circumference 6. Japanese Knee Osteoarthritis Measure (JKOM) 6-1. The score of visual analogue scale; VAS 6-2. The total score 6-3. The score of pain and stiffness in knees 6-4. The score of condition in daily life 6-5. The score of general activities 6-6. The score of health conditions 6-7. Individual items of the JKOM questionnaire 7. MOS Short-Form 36-Item Health Survey (SF-36) 7-1. Physical component summary (PCS) 7-2. Mental component summary (MCS) 7-3. Role/Social component summary (RCS) 7-4. Physical functioning 7-5. Role physical 7-6. Bodily pain 7-7. General health 7-8. Vitality 7-9. Social functioning 7-10. Role emotional 7-11. Mental health 8. The total score of Pittsburgh Sleep Quality Index, Japanese version (PSQI-J) 9. Specific IgE (cedar pollen, cypress pollen, Dermatophagoides pteronyssinus and house dust) * 1-5, 7-9 Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change. * 6 Measured at screening (before consumption) and at four weeks after the start of test-food consumption.

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	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: Four weeks Test food: Powder containing proteoglycan Administration: Take one pack, once a day with dinner. * If you forget to take the test food, take it before going to bed.
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who age between 20 and 59 when they provide written informed consent 3. Subjects between 22 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI) 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively high Body fat percentage at screening (before consumption)
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 use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. 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 participate another trial during this trial 9. Subjects who drink alcoholic beverages immoderately 10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	15

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	Hirosaki University Graduate School Of Medicine Microbiology and Immunology
Organization
Division
Category of Funding Organization	Other
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 11 Month 25 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	16
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 11 Month 19 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2019 Year 11 Month 26 Day
Last follow-up date	2020 Year 01 Month 31 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 11 Month 25 Day
Last modified on	2022 Year 08 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044097