None
Conditions
Interventions
Single ingestion of placebo tablets, and high fat loading
Single ingestion of active tablets containing 100 mg of lactic acid bacteria R037, and high fat loading
Single ingestion of active tablets con
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy men and women between 30 and 65 years of age 2.Fasting triglyceride level is between 80 and 149 mg/dL 3.Subject who don't have heavy drink habit 4.Agreed the informed consent
Exclusion criteria
Exclusion criteria: 01.Under medication 02.Who can't stop to take supplements which may affect lipid metabolism during the study 03.Who can't stop drinking two days before screening and each examination 04.Who have an allergy to test substance 05.Who have severe disease(s) including diabetes, kidney/liver disease, heart disease, or who have metabolic disease(s) including thyroid gland disease, adrenal disease or who is under medical treatment 06.Who have chronic disease and is under medication 07.Who have digestive disease or surgery history of digestive organ(s) affecting digestion and absorption of foods 08.Inadequate subject judged by screening 09.Judged anemia by screening and cannot tolerate frequent blood sampling 10.Who has diarrhea within 1 week from date of screening 11.Blood drawing over 200 mL within 1 month or over 400 mL within 3 months from date of informed consent 12.Familial hyperlipidemia 13.Drug addict and alcohol addict 14.Who is attending another study using different food supplement(s), pharmaceutical(s), and cosmetic(s). Or who will attend another study 15.Under pregnant, or nursing, willing to become pregnant during the study 16.Person who is inappropriate for the study judged by medical doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: 1.Area under the triglyceride level-time curve 2.Changes of triglyceride level Safety: 1. Doctor's questions 2. Subjective/Objective symptoms 3. Adverse events/Side effects 4. Blood pressures, Heart rate 5. Clinical laboratory tests at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1.Area under the RLP-cholesterol level-time curve 2.Changes of RLP-cholesterol level 3.Total cholesterol 4.HDL-cholesterol 5.LDL-cholesterol | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed