Safety Evaluation for Excessive Ingestion of Food Containing Pinitol
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000028319
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
1. Subjects who are under physician's advice, treatment and/or medication for diabetes. 2. Subjects whose HbA1c is >=6.5% 3. Subjects whose FBG is >=126 mg/dl. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods based on especially leguminous plants including soybeans, and ice plants, yeasts, gelatin and milk. 10. Subjects who regularly take medicine, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect glucose metabolism. 11. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 12. 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. 13. Pregnant or lactating women or women expect to be pregnant during this study. 14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 15. Any other medical and/ or health reasons unfavorable to participation into the current study 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 active test food during the ingestion period and the post ingestion period.
- Secondary Outcome Measures
Name Time Method 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), biochemical test (AST, ALT, gamma-GTP, ALP, LDH, BUN, CRE, UA, TC, LDL-C, HDL-C, TG, serum total protein, albumin, total bilirubin, A/G ratio, CPK, serum amylase, Na, Cl, K, Ca, P, Fe, 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.