UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059343 |
|---|---|
| Receipt number | R000067858 |
| Scientific Title | A study to evaluate the effect of test food ingestion on blood lipid metabolism |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 17:39:20 |
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Basic information
Public title
A study to evaluate the effect of test food ingestion on blood lipid metabolism
Acronym
A study to evaluate the effect of test food ingestion on blood lipid metabolism
Scientific Title
A study to evaluate the effect of test food ingestion on blood lipid metabolism
Scientific Title:Acronym
A study to evaluate the effect of test food ingestion on blood lipid metabolism
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food on lipid metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood lipids
Key secondary outcomes
Biochemical tests and physical examinations related to blood lipids
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 of test food, for 12 weeks
Interventions/Control_2
Intake of placebo, 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) Males and females aged 20 to 64 years at the time of obtaining consent
2) Subjects with LDL cholesterol levels below 140 mg/dL at screening, as calculated by the Friedewald formula
3) Subjects who fully understand the purpose and details of the study and voluntarily consent to participate
Key exclusion criteria
1) Subjects who currently have any medical condition under treatment, or who have a history of serious illnesses requiring pharmacological treatment
2) Subjects who are considered to have dyslipidemia or familial hypercholesterolemia
3) Subjects with food allergies or potential allergy risk to the test food
4) Subjects habitually using substances that may influence lipid metabolism, including drugs, FOSHU, functional foods, supplements, or health products
5) Subjects who habitually consume FOSHU, functional foods, or supplements and are unable to discontinue them during the study
6) Subjects with irregular lifestyles, such as shift or night workers
7) Subjects who drink daily and consume more than 20 g of pure alcohol per day
8) Subjects who smoke more than 20 cigarettes per day
9) Subjects unable to consume the test food as instructed
10) Subjects who use implantable medical electrical devices, such as pacemakers
11) Subjects who use implantable metallic medical devices
12) Subjects unable to maintain their pre-study lifestyle habits during the study period
13) Subjects unable to avoid significant deviations from their pre-study lifestyle during the study
14) Subjects who plan to become pregnant or breastfeed during the study
15) Subjects who have participated in other clinical studies within 3 months prior to the start of this study, are currently participating, or wish to participate in such studies during the study
16) Subjects with significantly abnormal values deviating from the reference range in physical measurements, physical examinations, or clinical laboratory tests prior to intake
17) Subjects who are judged to be unsuitable based on their responses to the background survey
18) Subjects who are judged unsuitable for the study by the principal investigator for other reasons
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Shimazu |
Organization
NIPPN CORPORATION
Division name
Central Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi-shi, Kanagawa
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@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 (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067858
