UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053228 |
|---|---|
| Receipt number | R000060506 |
| Scientific Title | Confirmation test of LDL-cholesterol lowering effect of myricetin and luteolin containing food for 12 weeks |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2024/12/16 11:08:07 |
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Basic information
Public title
Confirmation test of LDL-cholesterol lowering effect of myricetin and luteolin containing food for 12 weeks
Acronym
Confirmation test of LDL-cholesterol lowering effect of myricetin and luteolin containing food for 12 weeks
Scientific Title
Confirmation test of LDL-cholesterol lowering effect of myricetin and luteolin containing food for 12 weeks
Scientific Title:Acronym
Confirmation test of LDL-cholesterol lowering effect of myricetin and luteolin containing food for 12 weeks
Region
| Japan |
Condition
Condition
N/A (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the LDL-cholesterol lowering efficacy and safety when healthy male and female continuously ingested the test food for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL-cholesterol and amount of change
Key secondary outcomes
1)HDL-cholesterol and amount of change
2)Total cholesterol and amount of change
3)Triglycerides and amount of change
4)Body weight and amount of change
5)Body fat ratio and amount of change
6)BMI and amount of change
7)Waist circumference and amount of change
8)Hip circumference and amount of change
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food (capsules containing myricetin and luteolin) for 12 weeks
Interventions/Control_2
Intake the control food (capsules without myricetin and luteolin) for 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)Japanese males and females between the age 20-<65 Y at the time of filing the written consent
2)Healthy individuals who are not currently undergoing treatment for any serious disease
3)Those who have a BMI 23.0-<30.0 at screening
4)Those who have a blood LDL-cholesterol level between 120 and 139.
5)Those who are able to visit the designated facility on the scheduled visit date
6)Those who had provided written consent after fully understanding the purpose and content of this study
Key exclusion criteria
1)Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases
2)Those with history of cardiovascular diseases
3)Those who take drugs to improve glucose metabolism, lipid metabolism, or blood pressure
4)Those who regularly took medicines and/or health foods/supplements that could affect the outcomes of this study (including foods for specified uses (FOSHU), foods with functional claims (FFC), and foods with nutrient function claims (FNFC))(however, this did not apply to those who could discontinue the intake of such products at the time of providing consent)
5)Those with allergies associated with the test foods
6)Those who have been diagnosed with familial hyperlipidemia
7)Those who had experienced feeling unwell or deterioration of physical condition due to blood collection in the past
8)Those who had donated 200 mL or more blood from the earlier three month scheduled for the study or have plan to do so during the study period
9)Those who are currently participating in another clinical study or participated in another clinical study within the last four months
10)Excessive alcohol drinkers and heavy smokers
11)Those with highly irregular dietary habits
12)Those who wish to become pregnant, are pregnant women (including those who may become pregnant), or lactating mothers during the study period
13)Those who did not agree with the purpose of this study when it was explained to them earlier
14)Those who thought that the study doctor assigned is not qualified enough to evaluate for this study results
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Kyowa Trial Co., Ltd.
Institute
Department
Personal name
Yoshimichi Kozai
Funding Source
Organization
Ryusendo Co., Ltd.
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
Institutional Review Board of Yamazaki Otolaryngology Medical Corporation Clinic
Address
14-1-16 Kita 11-jo Nishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0011, Japan
Tel
011-757-3387
s-ito@kyowa-t.com
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
LSI札幌クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 20 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060506
