Healthy adults
Conditions
Interventions
Ingestion of nine capsules containing pinitol daily for 4 weeks.
Ingestion of nine placebo capsules daily for 4 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who meet the following criterion either a or b. a. Subjects whose FBG is>=100 mg/dl and <126 mg/dl or HbA1c >=5.6% and <6.5%. b. Subjects whose FBG is>=70 mg/dl and <100 mg/dl and HbA1c >=4.6% and <5.6%. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| 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), 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. | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed