N/A (healthy adults)
Conditions
Interventions
Placebo food (a single time intake) ->
Test food, containing HBF2019-03 (a single time intake)
Test food, containing HBF2019-03 (a single time intake) ->
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Healthy males and females aged 20-64 years old when informed consent. [2] Fasting serum triglyceride level is between 120 and 200 mg/dL. [3] Who don't large amount of alcohol habitually. [4] Who are judged not suffering from a disease by the investigator. [5] Individuals giving written informed consent.
Exclusion criteria
Exclusion criteria: [1] Who use medical products affecting lipid metabolism. [2] Who can't stop using supplements which affecting lipid metabolism during the study period. [3] Who can't abstinent from alcohol from two days before each examination. [4] Who are allergic to placebo food and/or test food and/or the ingredient of high-fat meal. [5] Who have a history of serious kidney damage, hepatopathy, heart disease, respiratory disease, endocrine disease, or any other metabolic disease(s) or who is under medical treatment. [6] Who have chronic disease and is under medication. [7] Who have digestive organ disease or surgical history affecting digestion and absorption of foods. [8] Who are judged inappropriate for the study by the investigator in the screening. [9] Who are diagnosed as severe anemia in screening and not suitable for frequent collection of blood. [10] Who had an onset diarrhea within a week from the date of screening, and/or who are prone to diarrhea on a daily basis. [11] Who with significantly different fasting serum triglycerides levels of each test day. [12] Who have little change in serum triglyceride level after intake high-fat meal, or who continue to rise 6 hours after the meal, or who are judged abnormal changes in serum triglyceride level by the investigator in the screening. [13] Who donated blood over 200mL in the past a month or over 400mL in the past 3 months from the date of informed consent. [14] Who are diagnosed as familial hyperlipidemia. [15] Who are drug addict and/or alcohol addict. [16] Who with irregular life rhythms such as shift workers or works late at night. [17] Who are participating in other studies that using food(s), pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent. [18] Who are or are possibly pregnant, or who are lactating, during the study period. [19] Who are judged inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of serum triglyceride level and AUC (area under the curve) (0-6hrs) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes Time course of serum RLP-cholesterol level and AUC (area under the curve) (0-6hrs) *Safety Doctor's questions | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed