None listed
Conditions
Interventions
Single intake of plant extract 2 hours before the loading meal Washout Single intake of plant extract 1 hour before the loading meal Washout Single intake of plant extract with the loading meal
Sponsors
Synapse planning Co.,Ltd.
TOYO SHINYAKU Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose fasting serum triglyceride levels are under 150 mg/dL. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent. (4) Subjects who are able to comply with the instructions given by the study staff (e.g., how to consume the load food).
Exclusion criteria
Exclusion criteria: Subjects (who) (1)contract diseases (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, peripheral vascular disorder, and/or serious metabolic disease). (2)use oral medications affecting lipid metabolism. (3)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting lipid metabolism during test periods. (4)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (5)currently undergoing treatment for a condition that may affect study results (6)have declared allergic reaction to ingredients contained in test foods or high-fat diets. (7)are diagnosed as anemic by screening tests and not suitable for frequent collection of blood, or have difficulty in collecting the prescribed amount of blood in fingertip blood collection. (8)are shiftworker and/or midnight-shift worker. (9)are under treatment for or have a history of drug addiction and/or alcoholism. (10)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week, or can't stop drinking from 3 days before each measurement. (11)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (12)are pregnant or planning to become pregnant or breastfeed during the study period. (13)are planning to participate and/or have participated in other clinical studies. (14)are judged as unsuitable for the current study by the investigator for other reasons. (15)have difficulty consuming the prescribed meal (dinner on the day before the test) and the load food (on the day of the test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum triglyceride AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Serum triglyceride | — |
Countries
Japan
Contacts
Public ContactSatoko Honpo
Synapse planning Co.,Ltd. Clinical Trials Division
Outcome results
None listed