Healthy subjects with normal level or slightly higher than normal level of fasting serum triglyceride
Conditions
Interventions
Ingestion of the placebo food(7 days) - washout period (3 weeks or more) - ingestion of the test food(7 days)
Ingestion of the test food (7 days) - washout period (3 weeks or more) - ingestion of the
Sponsors
Medical Corporation Shoureikan Shin-Sapporo Seiryou Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese males and females between the ages of 20 and 64 years old at the time of giving consent to participate in the study. (2) Subjects whose fasting triglyceride level is less than 200 mg/dL before lipid load at screening. (3) Subjects who can be available to the test site on the visit dates. (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 history of hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious illness. (2) Subjects with a surgical history of digestive system (except appendicectomy). (3) Subjects with chronic diseases under treatment. (4) Subjects with food allergies to the food ingredients used in the study. (5) Subjects who are pregnant or intend to become pregnant during the study or are lactating. (6) Subjects who are lactose intolerant or are susceptible to high-fat foods to show gastrointestinal symptoms. (7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) or excessive smokers (smoke more than 20 cigarettes per day). (8) Subjects who always take drugs or supplements which claim the effects such as suppressive absorption of sugar or lipid, or reduction of triglyceride, etc. (9) Subjects who participate in other clinical trial. (10) Subjects who may feel unwell or deteriorate due to repeated blood collection. (11) Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study. (12) Subjects who have a habit of skipping meals. (13) Subjects who work from 22:00 to 6:00 (shift workers, late night workers, etc., including part-time workers) (14) Subjects who due to religious or other reasons need to avoid consuming foods whose origin is not clearly indicated. (15) Subjects judged as unsuitable for this study by the investigator with other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of area under the concentration curve (AUC) in the change of triglyceride levels between groups after single ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of area under the concentration curve (AUC) in the triglyceride levels as is between groups after single ingestion. Between group comparison of triglyceride levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion. Between group comparison of remnant-like lipoprotein cholesterol levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion as well as comparison for those for the area under the concentration curve (AUC). Effects on the intestinal microflora after 7 days consecutive ingestion of test food. | — |
Countries
Japan
Contacts
Public ContactIsao Takehara
Clinical Support Corporation, Limited Food Service Division
Outcome results
None listed