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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043559
Receipt No. 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 2021/10/04

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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
Email 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
Email nakagawa768@eps.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 Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguroku, Tokyo
Tel 03-6452-2712
Email 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 No longer recruiting
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
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049681

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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