Healthy adult
Conditions
Interventions
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 butte
Sponsors
Rohto Pharmaceutical Co., Ltd
MG PHARMA Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Blood triglycerides | — |
Secondary
| Measure | Time frame |
|---|---|
| -RLP-C -Blood ketone bodies -Free fatty acids | — |
Countries
Japan
Contacts
Public ContactYukiko Sekii
Rohto Pharmaceutical Co., Ltd Internal Medicine and Functional Food Development Division
Outcome results
None listed