UMIN-CTR Clinical Trial

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

Condition
Condition	hypercholesterolemia
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

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

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

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Food1(Intake priod:12 weeks)
Interventions/Control_2	Food2(Intake priod:12 weeks)
Interventions/Control_3	Placebo(Intake priod:12 weeks)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)20 to 75 years at the time of informed consent and possible to visit. 2)Japanese males and females. 3)LDL-Cho >=140 mg/dl and <200 mg/dl.
Key exclusion criteria	1)Subjects who is taking the following medications within 3 months, or who is scheduled to take medication after informed consent to participate in this examination. Fibrate-based medicine (bezafibrate etc), nicotinic acid, azole antifungal drug (itraconazole etc), macrolide antibiotics(erythromycin etc), coumarin-based anticoagulants(warfarin), antacid(magnesium hydroxide, aluminium hydroxide), lopinavir and ritonavir combination drug,Simeprevir, eltrombopag. 2)Subjects using steroidal and non-steroidal medicines (internal medicine / topical medicine). 3)Subjects who regularly use chemicals (orlistat (Xenical, Arai )etc) affecting fat absorption. 4)Subjects who previous or present serious disease such kidney, liver, circulatory system, benign neoplasm,mental, dementing disorder. 5)Subjects who are alcoholics or previous. 6)Subjects with hypothyroidism, patients with hereditary muscle disease (muscular dystrophy etc) or their family history, or those with a history of drug-induced myopathy. 7)Subjects who are receiving medication in diabetic patients or hypertensive patients. 8)Subjects who have allergy related to the study foods. 9)Subjects who using health foods (supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol. 10)Subjects who are participating within 3 months or planning to participate in other clinical study. 11)Subjects who are pregnant or breast-feeding. 12)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
Target sample size	75

Research contact person
Name of lead principal investigator	Tsuyoshi Yamato
Organization	Medical Corporation Kouwakai Kouwa Clinic
Division name	Director
Address	6-33-17, komagome, toshima-ku, Tokyo, Japan
TEL	03-3917-8105
Email	info@kouwakai.jp

Public contact
Name of contact person	Masao Matsuoka
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg. 10th Fl., 5-31-19 Shiba,Minato-ku,108-0014,Japan
TEL	03-3431-1216
Homepage URL
Email	matsuoka@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 Day
Anticipated trial start date	2017 Year 08 Month 17 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	2017 Year 08 Month 03 Day
Last modified on	2018 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032641