None listed
Conditions
Interventions
Single intake of Capsules containing wheat albumin
Single intake of Capsules containing wheat albumin and carrageen
Single intake of Capsules containing cellulose
Sponsors
Nissin Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females equal to or more than 20 years and less than 65 years old 2. In the 75g oral glucose tolerance test, subjects with a fasting blood glucose level of 110 mg / dL or more and less than 126 mg / dL or a 2 hour value of 140 mg / dL or more and less than 200 mg / dL. 3. Possible study volunteer to visit 4. Subjects who recognize the object and contents of the study and submit the written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who develop diabetes (Recommended by Japan Diabetes Society). 2. Subjects who have a history of large surgery (gastrectomy,gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum. 3. Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases. 4. Subjects who experienced unpleasant feeling by drawing blood in the past. 5. Subjects who have difficulty drawing blood from the peripheral vein. 6. Subjects who donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study. 7. Subjects who are allergic to the test food or who have serious drugs or food allergies. 8. Shift worker and night worker. 9. Subjects whose eating habits are extremely irregular. 10. Heavy drinkers(Average of the amount of pure alcohol per day 40 g or more). 11. Heavy Smokers(More than 21 on average per day) 12. Subjects who are positive for one or more items in the results of virus / immunologic serology examination at the time of prior to the study 13. Pregnant women or breast-feeding women. 14. Subjects who regularly use medicines, health foods, etc. that may affect the study 15. Sujects who was judged ineligibles by clinician in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Efficacy> Area under the curve of blood glucose level from time zero to the 120 minutes. Blood glucose level at the time of blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> Cmax of blood glucose level Tmax of blood glucose level Area under the curve of blood insulin level from time zero to the 120 minutes Cmax of blood insulin level Tmax of blood insulin level | — |
Countries
Japan
Contacts
Public ContactYoshitaka Hatakeyama
New Drug Research Center, Inc. Clinical Research Dept.
Outcome results
None listed