UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of the reduction effect of LDL cholesterol
Acronym	A verification study of the reduction effect of LDL cholesterol
Scientific Title	A verification study of the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym	A verification study of the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects
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 reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. LDL cholesterol at 12 weeks after consumption (12w)
Key secondary outcomes	1. LDL cholesterol at four and eight weeks after consumption (4w, 8w) 2. The ratio of subjects within each group whose LDL cholesterol is less than 120 mg/dL at 12w 3. Total cholesterol, non HDL cholesterol, HDL cholesterol, the ratio of LDL cholesterol per HDL cholesterol, and triglyceride (TG)

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
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test beverage: Beverage containing dietary fiber Administration: In principle, dissolve one packet of the powder test food with 180 mL of water and drink it 15 minutes before each meal (breakfast, lunch, and dinner). Open the powder test food immediately before drinking it. If you reluctantly can not drink the test beverage 15 minutes before each meal, drink it until immediately before each meal.
Interventions/Control_2	Duration: 12 weeks Test beverage: Placebo beverage Administration: In principle, dissolve one packet of the powder test food with 180 mL of water and drink it 15 minutes before each meal (breakfast, lunch, and dinner). Open the powder test food immediately before drinking it. If you reluctantly can not drink the test beverage 15 minutes before each meal, drink it until immediately before each meal.
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 2. Men or women 3. Subjects aged 20 or more and less than 65 4. Healthy subjects 5. Subjects who have breakfast, lunch, and dinner every day 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose fasting TG level is less than 400 mg/dL 8. Subjects whose BMI is 18.5 or more and less than 30 at screening (before consumption; Scr) 9. Subjects whose LDL cholesterol is between 120 mg/dL and 139 mg/dL at Scr
Key exclusion criteria	Subjects 1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. currently taking medicines (include herbal medicines) and supplements 6. who are allergic to medications and/or the test-beverage-related products 7. who have a surgical history of either gastrointestinal disease influencing digestion and absorption or digestive organ, or current history of disorder such as stricture in digestive organ 8. who tend to have diarrhea or constipation on daily 9. who have a pre-existing or present condition of drug or alcohol dependence 10. whose daily average number of smoking cigarettes is 21 or more 11. whose daily average amount of drinking as pure alcohol is over 60 g 12. who are shift workers or late-night shift workers 13. who are pregnant, lactation, or planning to become pregnant 14. who suffer from COVID-19 15. who cannot prepare the test beverages according to pre-decided instructions and take them three times when eating each diet a day 16. who are collected blood or donated blood components either 200 mL within 28 days or over 400 mL within three months before the agreement to participate in this trial 17. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 18. 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 Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

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	NISSIN FOODS HOLDINGS 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	2022 Year 05 Month 11 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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 20 Day
Date of IRB	2022 Year 04 Month 20 Day
Anticipated trial start date	2022 Year 04 Month 28 Day
Last follow-up date	2022 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054406

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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