Healthy adults
Conditions
Interventions
Ingestion of 3 tablets of nanoparticulated brown rice germ extract daily for 12 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who meet the following criterion a, b or c. a.Subjects whose BMI is normal range and TG is normal range. b.Subjects whose BMI is >=23.0 kg/m2 and <30.0 kg/m2. c.Subjects whose TG is >=120 mg/dl and <150 mg/dl. 2.Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who are under physician's advice, treatment and/or medication for obese, hyperlipidemia and diabetes. 2.Subjects with familial hypercholesterolemia. 3.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 4.Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 6.Subjects with severe anemia. 7.Pre- or post-menopausal women complaining obvious physical changes. 8.Subjects who are at risk of having allergic reactions to drugs or foods, especially gramineae. 9.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP. 10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 11.Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism. 12.Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 13.Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 14.Pregnant or lactating women or women expect to be pregnant during this study. 15.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 16.Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of adverse effects related to ingestion of the active test food during the ingestion period and the post ingestion period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of adverse events during the ingestion period and the post ingestion period. BW, BFP, BMI, BP measured at the hospital, heart rate, hematological test (WBC, RBC, Hb, Ht, and Plt), WBC differential count, biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, total phospholipids, fasting blood glucose, HbA1c, glycoalbumin, insulin, HOMA-IR, serum total protein, albumin, total bilirubin, A/G ratio, CPK, serum amylase, Na, Cl, K, Ca, P, Fe, Mg, UIBC and TIBC) and urine analysis (pH, protein, sugar, urobilinogen, bilirubin, ketone bodies and occult blood) after 2 and 4 weeks of ingestion and 2 weeks after the end of ingestion. | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed