A study on the effects of test food on glucose behavior in huma
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-UMIN000037465
- Lead Sponsor
- Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 29
Not provided
1. Subjects with diabetes or borderline diabetes. 2. Subjects who fall under any of the following: ALT>200 IU/L, AST>200 IU/L, Gamma-GTP>200 IU/L, Total Bilirubin>2.0g/dl. 3. Subjects who are suspected acute and subacute hepatopathy. 4. Subjects with serious heart problems. 5. Subjects with renal dysfunction (serum creatinine > 2.0 mg/dL). 6. Subjects with tumor bearing. 7. Subjects who can't take medication according to instructions. 8. Subjects who had serious disease or have disease in treatment, and who are judged not to be suitable for this study. 9. Subjects with risk of allergy related to this study. 10. Subjects who have symptoms such as fever, sore throat, cough, diarrhea, vomiting etc and are suspected acute infectious diseases. 11. Subjects who participated in other clinical trials within 2 months. 12. Subjects who continuously take dietary fiber or supplements, foods for specified health use , that contain substances affecting blood glucose levels. 13. Subjects who are judged unsuitable for this study by principal investigator and doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood glucose levels, persistently measured by FreeStyle Libre Sensor (Abbott).
- Secondary Outcome Measures
Name Time Method Questionnaire : Sense of hunger Glycometabolism : HbA1c, FBS Liver function : ALT, AST, Gamma-GTP, Total Bilirubin, Albumin, ALP Renal function : Serum Creatinine Serum lipid : TC, TG, LDL-C, HDL-C, RLP-C Anthropometry : Weight, Abdominal circumference, Blood pressure, Body fat percentage, Physical activity