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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033970
Receipt No. 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

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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