UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study
Title of the study (Brief title)	The verification study for blood lipid reduction effects
Region	Japan

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

Objectives
Narrative objectives1	To identify effects of the test food ingestion on the blood lipids
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL-cholesterol at 12 weeks after the ingestion
Key secondary outcomes	1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, triglyceride (TG) 2. Body weight

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test material: gamma-Tocotrienol cupsule Dose: Take one capsule, once a day Administration: Take one capsule after dinner
Interventions/Control_2	Duration: 12 weeks Test material: Placebo Dose: Take one capsule, once a day Administration: Take one capsule after dinner
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 adults of 20 years old or more 2. LDL-cholesterol levels more than 120 mg/dL
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who eat Food with Functional Claims of the LDL-cholesterol reduction effects on a daily basis 5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis 6. Allergic to medicines or foods related to the test food of this trial 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Shimoda
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name	R & D Center
Address	1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL	0586865141
Email	kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person	Norihito Shimizu
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name	Food Development Dept. R & D Center
Address	1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL	0586865141
Homepage URL
Email	kaihatsu@mri.biglobe.ne.jp

Sponsor
Institute	ORYZA OIL & FAT CHEMICAL CO., LTD.
Institute
Department

Funding Source
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
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 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 05 Day
Anticipated trial start date	2017 Year 04 Month 19 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 04 Month 17 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030982