UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033875 |
|---|---|
| Receipt number | 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 17:45:18 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038634
