UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033970 |
|---|---|
| Receipt number | R000038734 |
| Scientific Title | Effect of the experimental diet on lipid metabolism |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/09/01 16:15:20 |
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Basic information
Public title
Effect of the experimental diet on lipid metabolism
Acronym
Effect on lipid metabolism
Scientific Title
Effect of the experimental diet on lipid metabolism
Scientific Title:Acronym
Effect on lipid metabolism
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with 12 week daily intake of active test food on blood lipid level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total blood cholesterol
Blood LDL cholesterol
Blood HDL cholesterol
Blood triglyceride
Key secondary outcomes
Body weight
BMI
Incidence of adverse and of side effects
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
Intake 6 capsules those contain test food three times a day (after each meal), for 12 weeks.
Interventions/Control_2
Intake 6 capsules those contain no test food three times a day (after each meal), for 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Males aged 40 to 60 at resistration.
2) LDL-cholesterol >= 120mg/dL
3) Subjects giving written informed consent.
Key exclusion criteria
1) Subjects who constantly use medicines, supplements having a possibility of affecting test results.
2) Subjects who have previous and/or current medical history of serious disease having a possibility of affecting test results.
3) Subjects who excessive alcohol intake and excess smoker.
4) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
5) Subjects who have previous medical history of drug and/or food (especially gelatin) allergy.
6) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
7) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
8) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
9) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
10) Subjects who are positive for infectious.
11) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Shioda |
Organization
SHIODA Life Science Inc.
Division name
President
Zip code
Address
Harks Roppongi Bildg. 6F, 6-15-21 Roppongi, Minato-ku, Tokyo, Japan
TEL
03-6804-5371
shioda@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Planning and Sales Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5927-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
SHIODA Life Science Inc.
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
| 2018 | Year | 09 | Month | 01 | 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
| 2018 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038734
