Healthy subjects with slightly higher fasting serum triglyceride level
Conditions
Interventions
single ingestion of the placebo food - washout period (6 days or more) - single ingestion of the test food
single ingestion of the test food - washout period (6 days or more) - single ingestion of th
Sponsors
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese males and females from 20 to 64 years of age when consented. (2)Healthy subjects whose fasting serum TG levels is slightly high at pre-, 1st and 2nd screenings and whose time courses of serum TG after loading dietary food resemble each other at 1st and 2nd screening. (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 appendicectom). (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 dietary life (shift worker, night- shift worker, etc.) (13) Subjects who had excessive eating and/or drinking during 3 days prior to each screening or prior to intervention period I or II. (14) Subjects who fasted repeatedly during 3 days prior to each screening or prior to intervention period I or II. (15) Subject who had excessive exercise than usual during 3 days prior to each screening or prior to intervention period I or II. (16) Subjects judged as unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The differences of serum TG level at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat) | — |
Secondary
| Measure | Time frame |
|---|---|
| The differences of serum level of remnant-like lipoprotein cholesterol at sequential sampling point and AUC 0-6h between placebo and test food groups (The analysis of the actual measured values and the amount of changed values from baseline after the loading dietary fat) Assessment of safety (subjective and objective symptoms and blood chemistry). | — |
Countries
Japan
Contacts
Public ContactRyo Kanamori
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Outcome results
None listed