UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	Effects of consumption of the test food in healthy Japanese normal to overweight subjects
Scientific Title	Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of the test food in healthy Japanese normal to overweight subjects
Region	Japan

Condition
Condition	Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the visceral fat reducing effect with the consumption of the test food for 12 weeks in Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The visceral fat area in a cross section of the umbilical region * Assess the fat area by X-ray CT * Calculate the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes	1. Total fat area 2. Subcutaneous fat area 3. Visceral fat area 4. Serum adiponectin level 5. Serum total cholesterol level 6. Serum HDL-cholesterol level 7. Serum LDL-cholesterol level 8. Serum neutral fat (TG: triglyceride) level 9. Serum glucose level 10. Height 11. Body weight 12. Body mass index 13. Body fat percentage 14. Body temperature 15. Abdominal circumference 16. Muscle mass 17. Basal metabolic rate 18. Subjective symptoms (A questionnaire) *1-9, 11-18 Assess these tests at screening (before consumption) and at 12 weeks after consumption *10 Measure the height only at screening (before consumption) *1-2 Assess these by X-ray CT. Measure the fat area of umbilicus cross section and calculate the amount of change between screening (before consumption) and 12 weeks after consumption. *3 Assess the measured value of the fat area in a cross section of the umbilical region by X-ray CT. *4-9, 11-17 Measure the items and calculate the amount of change between screening (before consumption) and 12 weeks after consumption. *18 Assess symptoms by the Likert scale. Each item is assessed with a six-point grading scale from 1 (strongly disagree) to 6 (strongly agree). The smaller number indicates better condition.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: Capsules containing an enzyme Dose: Take 2 capsules per day Administration: Take 2 capsules after breakfast * If you forget to take capsules, take these as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test material: Placebo capsule Dose: Take 2 capsules per day Administration: Take 2 capsules after breakfast * If you forget to take capsules, take these as soon as you remember within the day.
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 between 23 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. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose visceral fat area of umbilicus cross section are relatively large
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, endometriosis, uterine myoma, and mental disorders 2. 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 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who have exercise habits more than 3 times per week 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, lactation, or 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 9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
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 Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
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	HEALTH UP INC.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	ORTHOMEDICO Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 07 Month 02 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	2018 Year 06 Month 25 Day
Date of IRB	2018 Year 06 Month 25 Day
Anticipated trial start date	2018 Year 07 Month 03 Day
Last follow-up date	2018 Year 12 Month 15 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 07 Month 02 Day
Last modified on	2020 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037894