Healthy adults
Conditions
Interventions
Daily ingestion 4.5 g of decaffeinated green coffee bean extract powder for 4 weeks.
Daily ingestion 4.5 g of lactose powder for 4 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2. Subjects whose TG is >= 30 mg/dl and <= 149 mg/dl.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment and/or medication for dyslipidemia and/or diabetes. 2. Subjects with familial hypercholesterolemia. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal disease, 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, abnormal physical data and/or abnormal hematological data. 6. Subjects with severe anemia. 7. Pre- or post-menopausal women complaining of obvious physical changes. 8. Subjects who are at risk of having allergic reactions to drugs, foods especially based on coffee, milk, egg, wheat, shrimp, soybean, chicken, and/or pork. 9. Subjects with lactose intolerance. 10. Subjects who regularly take medicines, functional foods, and/or supplements which would affect lipid metabolism. 11. Subjects who regularly take medicines, functional foods and/or supplements which would affect glucose metabolism. 12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participate within the last 4 weeks prior to the study. 16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of side effects related to ingestion of the test food during the ingestion period (4 weeks) and the post ingestion period (2 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of adverse events during the ingestion period (4 weeks) and the post ingestion period (2 weeks). Body composition (BW, BFP, and BMI), vital sign (BP measured at the hospital, and heart rate), hematological test (WBC, RBC, Hb, Ht, and Plt), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, FIB-4 index, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, fasting blood glucose, HbA1c, total protein, albumin, total bilirubin, A/G ratio, CPK, Na, Cl, K, Ca, P, Mg, and Fe) and urine analysis (pH, protein, sugar, urobilinogen, bilirubin, ketone bodies, and occult blood) after 2 and 4 weeks of ingestion and 2weeks after the end of ingestion. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed