Healthy volunteer
Conditions
Interventions
Consume one test food a day (for 3day)->
Washout (for 4 days) ->
Consume one placebo food a day (for 3day)
Consume one placebo food a day (for 3day)->
Consume one test food a day (for 3day)
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy volunteer 2.Males and females aged between 20 and 59. 3. Subjects who receive adequate explanation for participation in this research and provide informed consent in writing by their own free will. 4. Subjects who can take certainly foods according to instructions, and understand how to use wearable blood glucose monitoring equipment and wearable physical activity meter. Subjects who can write Life diary and Questionnaire. 5. Subjects who are judged suitable for this study by principal investigator and doctors.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose levels, persistently measured by FreeStyle Libre Sensor (Abbott). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasuhiro Nishizaki
Tokai University School of Medicine Dept. of Clinical Health Science
Outcome results
None listed