Healthy volunteer
Conditions
Interventions
1. Single intake of the test food 2. 1 week washout period 3. Single intake of the placebo food
1. Single intake of the placebo food 2. 1 week washout period 3. Single intake of the test food
Sponsors
Nissin Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese Males and females aged of 20-64 years 2) Subjects whose fasting blood glucose levels are less than 126 mg/dL, postprandial blood glucose levels are 140 mg/dL or more at 30, 45 or 60 minutes after meal and 199 mg/dL or less at 120 minutes after meal 3) Possible study volunteer to visit 4) Individuals whose written informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1) Subjects who develop diabetes 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, those who will use them during the period of the study, or those who need to take foods listed in Attachment 1 15) Subjects who was judged ineligibles by clinician in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental Area Under the Curve of blood glucose level delta Cmax of blood glucose level delta Blood glucose level at each blood sampling time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve of blood glucose level Tmax of blood glucose level Cmax of blood glucose level Blood glucose level at each blood sampling time point Incremental Area Under the Curve of serum insulin level Area under the curve of serum insulin level Cmax of serum insulin level Tmax of serum insulin level delta Serum insulin level at each blood sampling time point Serum insulin level at each blood sampling time point | — |
Countries
Japan
Contacts
Public ContactShimpei Tomita
New drug research center, Inc. Research Dept.
Outcome results
None listed