UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027024 |
|---|---|
| Receipt number | 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 09:48:28 |
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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
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
kaihatsu@mri.biglobe.ne.jp
Sponsor or person
Institute
ORYZA OIL & FAT CHEMICAL CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030982
