UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol
Acronym	A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol
Scientific Title	A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol: A randomized double-blind placebo-controlled, parallel-group trial
Scientific Title:Acronym	A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol
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 reducing effects of consumption of the test-food on LDL cholesterol.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured value of LDL cholesterol at 12 weeks after the start of test-food consumption
Key secondary outcomes	1. The measured value of LDL cholesterol at four and eight weeks after the start of test-food consumption 2. The amount of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption 3. The rate of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption 4. The ratio of number of subjects whose LDL cholesterol levels are less than 120 mg/dL at 12 weeks after the start of test-food consumption 5-1. The measured values of the following items 5-2. The amount of changes of the following items [Items] total cholesterol, HDL cholesterol, flow mediated dilation (FMD), maximum expansion width of vessel, diameter of vessels at rest, blood flow velocity, visibility of vessels, density of vessels, diameter of vessels, distance between vessels and length of vessels 6. The ratio of number of subjects whose blood vessels are straight and shaped like hairpins, twisted and various shapes, irregular such as branches, or look short (hard to see) after four, eight and 12 weeks after the start of test-food consumption 7. The measured values of each item of original questionnaires at four, eight and 12 weeks after the start of test-food consumption

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Capsule containing fish oil Administration: Take three capsules per day at any time during the day. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test food: Placebo capsule Administration: Take three capsules per day at any time during the day. * If you forget to take the test food, take it 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. Healthy Japanese adult subjects 2. Subjects whose LDL cholesterol level was high in the most recent health checks 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose LDL cholesterol levels are 120 mg/dL or more and 139 mg/dL or less at screening
Key exclusion criteria	1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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 as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending 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 are judged as ineligible to participate in the study by the physician
Target sample size	52

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	EGAO CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi 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	IRB@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) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 22 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	53
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	2020 Year 05 Month 13 Day
Date of IRB	2020 Year 05 Month 13 Day
Anticipated trial start date	2020 Year 05 Month 19 Day
Last follow-up date	2020 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 22 Day
Last modified on	2022 Year 11 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046217