Healthy adult
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy males and females aged between 20 and 50 (2) Subjects who have a difference within 25% in the incremental area under the curve (IAUC) of two preliminary tests (3) Women have a stable menstrual cycle (4) Subjects with blood glucose level greater than 70 mg /dL or more and 110 mg /dL or less in glucometer
Exclusion criteria
Exclusion criteria: (1) Subjects routinely taking medicine or health food which may influence glucose metabolism (2) Subjects whose BMI exceeds 30.0 kg/m2 (3) Subjects whose blood glucose level exceeds 126 mg/dL (4) Subjects who have been pointed out as impaired glucose tolerance within 1 year (5) Subjects who are suspected as impaired glucose tolerance in preliminary examination (6) Subjects whose blood glucose level exceeds 110 mg/dL in glucometer on admission (7) Subjects planned to travel abroad during the study period (8) Subjects having possibilities for emerging allergy related to the current study (9) Subjects who drink much alcohol (10) Subjects who do excessive smoking (11) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or 400 mL within 4 months (12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (13) Subjects who have under treatment (e.g.,adiposity,hyperlipidemia, hypertension) that affects the evaluation of this study or medical history of serious illness for medication (14) Subjects whose values of physical measurement, physical examination and clinical laboratory are significantly different from the reference range (15) Subjects who may be pregnant or are pregnant, breastfeeding, or those who desire pregnancy during the study period (16) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (18) Subjects who are judged as ineligible by the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum blood glucose level (Cmax) Amount of change in blood glucose levels based on the blood glucose level before loading, Incremental area under the blood glucose response curve (IAUC), Area under the curve(AUC) Amount of change in insulin levels based on the insulin level before loading, Incremental area under the insulin response curve (IAUC), Area under the curve(AUC) Amount of change in questionnaire on Appetite(VAS-questionnaire) based on the appetite(VAS-questionnaire) before loading | — |
Countries
Japan
Contacts
TTC Co., Ltd. Clinical Research Planning Department