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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033875
Receipt No. R000038634
Scientific Title Effect of supplements on the blood cholesterol levels -A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Date of disclosure of the study information 2018/08/24
Last modified on 2019/02/01

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Basic information
Public title Effect of supplements on the blood cholesterol levels
-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Acronym Effect of supplements on the blood cholesterol levels
Scientific Title Effect of supplements on the blood cholesterol levels
-A placebo-controlled, randomized, double-blind, parallel-group comparative study-
Scientific Title:Acronym Effect of supplements on the blood cholesterol levels
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of supplements on the blood LDL cholesterol levels.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood LDL cholesterol levels
Key secondary outcomes blood total cholesterol levels
blood non-HDL cholesterol levels

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Test food(Intake priod:12 weeks)
Interventions/Control_2 Placebo(Intake priod: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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy male and female aged 20 to 64 years at the time of informed consent.
2)LDL cholesterol levels>=120 mg/dl and <160 mg/dl.
3)Subjects who agree to participate in the study on one's own will.
Key exclusion criteria 1)Subjects who are suffering or suffered from serious disease such as kidney, liver, circulatory system, malignant neoplasm, mental, dementing disorder.
2)Subjects who are suffering or suffered from alcohol abuse disorder.
3)Subjects who are receiving medication.
4)Subjects who have allergy related to the study foods.
5)Subjects who cannot stop using health foods(supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol while study term.
6)Subjects who have participated in other clinical studies within the past 3 months prior to obtaining of the informed consent, or who are planning to participate in other clinical studies during the present study.
7)Subjects who are pregnant or breast-feeding.
8)Subject who cannot stop drinking alcohol from 2 days before screening inspection and each examination.
9)Subject who are shift workers, or late night workers.
10)Subjects who have been diagnosed with familial hyperlipidemia.
11)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 日本橋循環器科クリニック(東京都) / Nihonbashi Cardiology Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 24 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 08 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 25 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
2018 Year 08 Month 23 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038634

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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