Safety Evaluation for Excessive Ingestion of Coffee-Derived Chlorogenic Acids: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000044543
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.