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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037551
Receipt No. R000042776
Scientific Title Effect of daily intake of the test food on cholesterol and Arteriosclerosis
Date of disclosure of the study information 2019/08/01
Last modified on 2020/03/31

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Basic information
Public title Effect of daily intake of the test food on cholesterol and Arteriosclerosis
Acronym Effect of daily intake of the test food on cholesterol and Arteriosclerosis
Scientific Title Effect of daily intake of the test food on cholesterol and Arteriosclerosis
Scientific Title:Acronym Effect of daily intake of the test food on cholesterol and Arteriosclerosis
Region
Japan

Condition
Condition LDL choresterol 120-159mg/dL adult men and women
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the effect of the test food on cholesterol and arteriosclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL cholesterol
Key secondary outcomes Total cholesterol, HDL cholesterol, non-HDL cholesterol, triglyceride (TG), remnant-like Particle cholesterol (RLP-C), MDA-LDL, apolipoprotein B, lipoprotein fractionation (VLDL, small -dense LDL, LDL, HDL), LOX-index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Test food A containing EPA・DHA: 7 capsules/day for 12 week
Interventions/Control_2 Test food B not containing EPA・DHA: 7 capsules/day for 12 week
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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) LDL-cholesterol >=120 mg/dl and <159 mg/dl
2) Subjects aged 30 to 70 years old
3) Gender: No preference
4) Subjects without smoking habits
5) Subjects who do not have a habit of taking a meal containing a large amount of the test foods
6) Subjects who do not regularly use health foods
7) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases
8) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction
9) Subjects who have no history of allergy to test foods/medicines
10) Subjects who do not take medication for Outpatient treatment
11) Subjects giving written informed consent
Key exclusion criteria 1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study
3) Subjects who do not comply with instructions from the doctor or medical staff
4) Others who have been determined ineligible by investigator
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Naotaka
Middle name
Last name Hashiya
Organization Kanyukai clinic
Division name Head
Zip code 553- 0004
Address 2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
TEL 06-6444-7788
Email hashiya@carna-medsalon.jp

Public contact
Name of contact person
1st name Taisuke
Middle name
Last name Fukaya
Organization Tashikani Plus Co., Ltd
Division name CEO
Zip code 530-0041
Address 6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
TEL 06-6352-6622
Homepage URL
Email fukaya@tashikani.jp

Sponsor
Institute Tashikani Plus Co., Ltd
Institute
Department

Funding Source
Organization non-disclosure
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 Japan Food Evidence Association
Address 7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
Tel 06-6352-6622
Email info@food-evidence.jp

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
2019 Year 08 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
2019 Year 07 Month 29 Day
Date of IRB
2019 Year 07 Month 30 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2019 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 31 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042776

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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