UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048222 |
|---|---|
| Receipt number | R000054952 |
| Scientific Title | Functional evaluation of cholesterol level reduction in humans |
| Date of disclosure of the study information | 2022/07/04 |
| Last modified on | 2023/07/03 11:41:13 |
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Basic information
Public title
Functional evaluation of cholesterol level reduction in humans
Acronym
Functional evaluation of cholesterol level reduction in humans
Scientific Title
Functional evaluation of cholesterol level reduction in humans
Scientific Title:Acronym
Functional evaluation of cholesterol level reduction in humans
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of reducing LDL cholesterol level and safety of research food during continuous intake for 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL-cholesterol
Key secondary outcomes
Total cholesterol, HDL-cholesterol, LDL cholesterol-HDL cholesterol ratio, non-HDL cholesterol, Atherogenic index, triglycerides
special clinical examination items (sd LDL cholesterol, oxidized LDL cholesterol, remnant-like lipoprotein-cholesterol)
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 research food 3 tablets daily for 12 weeks
Interventions/Control_2
Intake placebo 3 tablets daily 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male and female at the age of 20 to 64.
(2) LDL cholesterol level at the time of pre-examination 2 test is 120 mg/dL or more and less than 140 mg/dL.
(3) Triglyceride level at the time of pre-examination 2 is less than 150 mg/dL.
Key exclusion criteria
(1) Those who regularly intake foods, health foods, or medicines that are rich in active ingredients of research foods.
(2) Those who are currently, or within the past 3 months have been, in the habit of continuously intaking foods with functional claims or health foods that claim to be related to lipid or glucose metabolism, or are planning to intake such foods during the study period.
(3) Those with a history of dyslipidemia, hypertension, diabetes, psychiatric disorders, sleep disorders, or serious illnesses, or a history of continuous drug treatment.
(4) Those with a BMI of 30 kg/m2 or higher.
(5) Those who are at risk of developing allergies related to the research.
(6) Those whose daily alcohol consumption exceeds an average of 60 g/day of pure alcohol equivalent.
(7) Those who are judged to be unsuitable as a subject based on the results of the lifestyle questionnaire.
(8) Those whose physical measurements, physical test values, and clinical test values before the start of ingestion show significant deviations from the standard range.
(9) Those who are currently participating in other clinical tests, or those who have not passed 3 months after participation in other clinical tests.
(10) Those who plan to become pregnant or breastfeed during the study period.
(11) Those who are likely to change their lifestyle during the study period (e.g., long trips, etc.).
(12) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Kobayashi |
Organization
KOBAYASHI PHARMACEUTICAL CO., LTD.
Division name
Research & Development Dept., Healthcare Products Division
Zip code
567-0057
Address
1-30-3 Toyokawa, Ibaragi-shi, Osaka
TEL
080-3452-9955
masa-kobayashi@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section
Zip code
162-0821
Address
1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI PHARMACEUTICAL 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 04 | 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
| 2022 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054952
