UMIN-CTR Clinical Trial

Basic information
Public title	Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study-
Acronym	Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement
Scientific Title	Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study-
Scientific Title:Acronym	Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement
Region	Japan

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

Objectives
Narrative objectives1	To assess the effectiveness and safety of intake of test supplement on serum LDL-cholesterol using placebo as a control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	LDL-cholesterol level (Friedewald Equation)
Key secondary outcomes	Total cholesterol level, non-HDL cholesterol level, HDL-cholesterol level, triglyceride level, ratio of LDL-cholesterol and HDL-cholesterol, subgroup analysis

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test supplement for 12 consecutive weeks
Interventions/Control_2	Intake of placebo for 12 consecutive weeks
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. Male and female whose age is between 20 and 65 years old. 2. Subjects whose serum LDL-cholesterol levels are between 120 mg/dl and 140 mg/dL at the baseline test.
Key exclusion criteria	1. Subjects who routinely use pharmaceuticals, FOSHU, food with function claim, or health foods that affect serum lipid levels or lipid metabolism. 2. Subjects whose fasting serum triglyceride level are higher than 400 mg/dL at screening test. 3. Subjects who routinely use large amount of functional ingredients contained in test supplements 4. Subjects with a disease under treatment or with a history of serious disease that required medication. 5. Subjects who have or have had a serious disease such as diabetes, liver disease, kidney disease, or heart disease. 6. Subjects who are unable to perform the test according the prescribed procedure (e.g., enter web questionnaires, and web diary, fill out dietary records). 7. Subjects who are judged to be unsuitable to participate in the study based on answers of background survey. 8. Subjects who have allergy related to this study. 9. Subjects whose clinical laboratory tests, blood pressure, and physical measurements before intake of trial supplements are significantly out of the standard values. 10. Subjects who have participated in other clinical studies. 11. Subjects who intend to become pregnant or lactating. 12. Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	FANCL Research Institute
Zip code	2440806
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Nakagawa
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	nakagawa768@eps.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	saito876@eps.co.jp

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	メディカルステーションクリニック、医療法人社団 絆 アーバンハイツクリニック

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 12 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	90
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	2021 Year 02 Month 25 Day
Date of IRB	2021 Year 02 Month 25 Day
Anticipated trial start date	2021 Year 03 Month 20 Day
Last follow-up date	2021 Year 08 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2022 Year 02 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049681