Slightly higher fasting serum triglyceride level (from 120 to no more than 200 mg/dL)
Conditions
Interventions
single ingestion of a placebo food - washout period (6 days or more) - single ingestion of a test food
single ingestion of a test food - washout period (6 days or more) - single ingestion of a placebo
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy Japanese males and females from 20 to 64 years of age when consented. (2)Subjects whose fasting serum triglyceride levels are less than 150 mg/dL. Most of them desirably have triglyceride level of 120 - 149 mg/dL. (3)Subjects available at every designated visit. (4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: (1)Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. (2)Subjects with a surgical history of digestive system (except appendicectomy) (3)Subjects with a history of a previous drug or food allergy. (4)Subjects currently under treatment with chronic diseases. (5)Subjects who are pregnant or intend to become pregnant during the study or are lactating. (6)Subjects who are lactose intolerant or sensitive to fatty diet to show gastrointestinal symptoms. (7)Subjects who take excessive alcohol (equivalent to 540 mL of Japanese sake or more) for 5 days or more per week. (8)Subjects who take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc. (9)Subjects who participate in other clinical trial (10)Subjects who have a history of feeling ill or unwell during or after blood drawing. (11)Subjects who have donated over 200 mL of blood within the last one month prior to this study or expect to donate the same during the study. (12)Subjects with extremely irregular diet (shift worker, night-shift worker, etc.) (13)Subjects judged as unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of serum triglyceride level and AUC 0-6 for actual measured values as well as amount of changed values after intake of dietary fat. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time course of serum RLP-cholesterol level and AUC 0-6 for actual measured values and amount of changed values after intake of dietary fat. Assessment of safety(subjective and objective symptoms and blood biochemistry). | — |
Countries
Japan
Contacts
Public ContactRyota Wakimoto
Medical Corporation Hokubukai Utsukushigaoka Hospital
Outcome results
None listed