The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000038037
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time course of serum triglyceride level and AUC (area under the curve) (0-6hrs)
- Secondary Outcome Measures
Name Time Method *Secondary outcomes Time course of serum RLP-cholesterol level and AUC (area under the curve) (0-6hrs) *Safety Doctor's questions