UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043559 |
|---|---|
| Receipt number | R000049681 |
| Scientific Title | Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study- |
| Date of disclosure of the study information | 2021/03/12 |
| Last modified on | 2022/02/01 14:01:33 |
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Basic information
Public title
Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study-
Acronym
Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement
Scientific Title
Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study-
Scientific Title:Acronym
Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness and safety of intake of test supplement on serum LDL-cholesterol using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
LDL-cholesterol level (Friedewald Equation)
Key secondary outcomes
Total cholesterol level, non-HDL cholesterol level, HDL-cholesterol level, triglyceride level, ratio of LDL-cholesterol and HDL-cholesterol, subgroup analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement for 12 consecutive weeks
Interventions/Control_2
Intake of placebo for 12 consecutive 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. Male and female whose age is between 20 and 65 years old.
2. Subjects whose serum LDL-cholesterol levels are between 120 mg/dl and 140 mg/dL at the baseline test.
Key exclusion criteria
1. Subjects who routinely use pharmaceuticals, FOSHU, food with function claim, or health foods that affect serum lipid levels or lipid metabolism.
2. Subjects whose fasting serum triglyceride level are higher than 400 mg/dL at screening test.
3. Subjects who routinely use large amount of functional ingredients contained in test supplements
4. Subjects with a disease under treatment or with a history of serious disease that required medication.
5. Subjects who have or have had a serious disease such as diabetes, liver disease, kidney disease, or heart disease.
6. Subjects who are unable to perform the test according the prescribed procedure (e.g., enter web questionnaires, and web diary, fill out dietary records).
7. Subjects who are judged to be unsuitable to participate in the study based on answers of background survey.
8. Subjects who have allergy related to this study.
9. Subjects whose clinical laboratory tests, blood pressure, and physical measurements before intake of trial supplements are significantly out of the standard values.
10. Subjects who have participated in other clinical studies.
11. Subjects who intend to become pregnant or lactating.
12. Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
2440806
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 | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
nakagawa768@eps.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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito876@eps.co.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
メディカルステーションクリニック、医療法人社団 絆 アーバンハイツクリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 12 | 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
90
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
| 2021 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | 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=R000049681
