UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of supplements on the blood cholesterol levels -A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Title of the study (Brief title)	Effect of supplements on the blood cholesterol levels
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of supplements on the blood LDL cholesterol levels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood LDL cholesterol levels
Key secondary outcomes	blood total cholesterol levels blood non-HDL cholesterol levels

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food(Intake priod:12 weeks)
Interventions/Control_2	Placebo(Intake priod:12 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)Healthy male and female aged 20 to 64 years at the time of informed consent. 2)LDL cholesterol levels>=120 mg/dl and <160 mg/dl. 3)Subjects who agree to participate in the study on one's own will.
Key exclusion criteria	1)Subjects who are suffering or suffered from serious disease such as kidney, liver, circulatory system, malignant neoplasm, mental, dementing disorder. 2)Subjects who are suffering or suffered from alcohol abuse disorder. 3)Subjects who are receiving medication. 4)Subjects who have allergy related to the study foods. 5)Subjects who cannot stop using health foods(supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol while study term. 6)Subjects who have participated in other clinical studies within the past 3 months prior to obtaining of the informed consent, or who are planning to participate in other clinical studies during the present study. 7)Subjects who are pregnant or breast-feeding. 8)Subject who cannot stop drinking alcohol from 2 days before screening inspection and each examination. 9)Subject who are shift workers, or late night workers. 10)Subjects who have been diagnosed with familial hyperlipidemia. 11)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
Target sample size	80

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.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)

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	日本橋循環器科クリニック(東京都) / Nihonbashi Cardiology Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 09 Day
Anticipated trial start date	2018 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 23 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038634