Healthy Adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who is 20 years old or more and under 64 years old 3.Persons whose BMI is 23 or more at screening
Exclusion criteria
Exclusion criteria: 1.Persons who have a chronic disease and is under medication, or has a serious disease history 2.Persons whose HOMA-IR at screening is 2.5 or more 3.Persons whose fasting blood glucose level at screening is 126 mg/dL or more 4.Persons whose LDL cholesterol at screening is 140 mg/dL or more 5.Persons whose blood neutral fat at screening is 150 mg/dL or more 6.Persons who are allergic to the test food 7.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 8.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 9.Persons who are judged inappropriate for the exam by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin resistance (glucose, HbA1c, insulin, HOMA-IR, AUC, Cmax, C, myoinositol, creatinine) at the beginning of the test or after ingestion of 4, 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Cholesterol (total cholesterol, LDL-cholesterol), blood neutral fat (TG), general blood biochemical test (HDL-cholesterol, AST, ALT, g-GT, urea nitrogen, creatinine , TNF-a, IL-1b, IL-6, IL-10, BDNF), intestinal environment (urine, albumin, total protein, ALP, LD, sodium, chlorine, potassium, calcium, inorganic phosphorus, magnesium, free fatty acid, (indoxyl sulfate, creatinine, short chain fatty acid, intestinal bacteria), stress (IgA), physical examination (body weight, blood pressure, pulse rate, BMI), questionnaire, at the beginning of the test or after ingestion of 4, 8 and 12 weeks | — |
Countries
Japan
Contacts
Healthcare Systems Co., Ltd. Research and Development