UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060780 |
|---|---|
| Receipt number | R000069533 |
| Scientific Title | Postprandial Blood Lipid Evaluation Study |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/27 17:55:53 |
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Basic information
Public title
Postprandial Blood Lipid Evaluation Study
Acronym
Postprandial Blood Lipid Evaluation Study
Scientific Title
Postprandial Blood Lipid Evaluation Study
Scientific Title:Acronym
Postprandial Blood Lipid Evaluation Study
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 postprandial blood lipid levels in postmenopausal women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Blood triglycerides
Key secondary outcomes
-RLP-C
-Blood ketone bodies
-Free fatty acids
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Single intake of the high-fat load meal and the test food - Washout period - Single intake of the high-fat load meal and the placebo food.
High-fat load meal: corn soup prepared by dissolving butter and lard and adjusted to contain at least 40 g of fat
Interventions/Control_2
Single intake of the high-fat load meal and the placebo food - Washout period - Single intake of the high-fat load meal and the test food.
High-fat load meal: corn soup prepared by dissolving butter and lard and adjusted to contain at least 40 g of fat
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Postmenopausal women aged 45 years or older and younger than 65 years at the time of informed consent.
2. Individuals with elevated fasting blood triglyceride levels.
3. Individuals who have received a full explanation of the study objectives and procedures, have voluntarily agreed to participate, and have provided written informed consent.
Key exclusion criteria
1. Individuals with a history of serious illness or gastrointestinal resection (excluding appendectomy).
2. Individuals who are currently using medications that may affect the study outcomes, or who have used such medications within 4 weeks prior to informed consent.
3. Individuals who habitually consume foods with functional claims or dietary supplements related to lipid or glucose metabolism, or who plan to consume such products during the study period.
4. Individuals with allergies to the test food or the high-fat load meal, or those at risk of developing severe allergic reactions to other foods or medications.
5. Individuals who have donated more than 200 mL of blood within the past month, or more than 400 mL within the past 3 months.
6. Individuals who have repeatedly experienced feeling unwell or deterioration of physical condition during previous blood draws.
7. Individuals with severe anemia.
8. Individuals currently undergoing hormone replacement therapy, or who have undergone such therapy within 3 months prior to obtaining informed consent.
9. Individuals who have difficulty consuming the full amount of the test meal and/or the test food (including due to palatability).
10. Individuals whose average daily alcohol intake exceeds 60 g of alcohol per day.
11. Individuals who are likely to change their lifestyle habits (diet, sleep, exercise, etc.) during the study period (e.g., long-term travel).
12. Individuals who are currently participating in another clinical study, or who have participated in another clinical study within the past 3 months.
13. Individuals who are otherwise deemed unsuitable for participation in this study by the principal investigator or sub-investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Sekii |
Organization
Rohto Pharmaceutical Co., Ltd
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
TEL
06-6758-9848
sekii@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sekii |
Organization
Rohto Pharmaceutical Co., Ltd
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
TEL
06-6758-9848
Homepage URL
sekii@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
MG PHARMA Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rohto Pharmaceutical Co., Ltd. Clinical Research Ethics Review Committee
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
Tel
06-6758-6925
rohtoirb@rohto.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
DRC株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 28 | 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
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069533
