UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027024
Receipt No. R000030982
Scientific Title The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study
Date of disclosure of the study information 2017/09/30
Last modified on 2017/10/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study
Acronym The verification study for blood lipid reduction effects
Scientific Title The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Shimoda
Organization ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name R & D Center
Zip code
Address 1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL 0586865141
Email kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Shimizu
Organization ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name Food Development Dept. R & D Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 04 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.