Healthy adult
Conditions
Interventions
Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intak
Sponsors
TTC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females aged between 20 and 50 (2) Subjects who are appropriate based on the IAUC of the test using the reference food (Stage I to III) (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 who have a history of diabetes (2) Subjects who are diabetic borderline in stage I to III (Fasting plasma glucose level is >= 110 mg/dL or glucose level after a reference food load of 120 minutes is >= 140 mg/dL) (3) Subjects who have a habit of smoking (4) Subjects with BMI of 25.0 kg/m2 or more or less than 18.5 kg/m2 (5) Subjects routinely taking medicine or health food which may influence glucose metabolism (6) Subjects who have been indicated as abnormal with impaired glucose tolerance test prior 1 year prior to stage I (7) Subjects who are suspected to have abnormal glucose tolerance in stage I (8) Subjects who are planning to travel abroad during the study period (9) Subjects having possibilities for emerging allergy related to the study (10) Subjects who consume large amounts of alcohol (the average alcohol amount is 60 g / day or more) (11) Subjects having blood sample of 200 ml or more taken within one month, or 400 ml or more within 4 months prior to the start of the study (12) Subjects who has under treatment or a history of serious disease (e.g., liver disease, kidney disease, heart disease, or gastrointestinal disease) (13) Subjects who has under treatment or a history of serious disease that affects the evalution of the study (e.g., obesity, dyslipidemia, or hypertension) (14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (15) Subjects who intend to become pregnant or lactating (16) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (18) Subjects judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum blood glucose level (Cmax), Incremental area under the blood glucose response curve (IAUC), Area under the curve (AUC) Maximum insulin level (Cmax), Incremental area under the insulin response curve (IAUC), Area under the curve (AUC) Change in blood glucose levels based on the blood glucose level before test food ingestion Change in insulin levels based on the insulin level before test food ingestion Change in blood glucose levels based on the blood glucose level before second meal ingestion Change in insulin levels based on the insulin level before second meal ingestion Change in questionnaire on appetite (VAS-questionnaire) based on the appetite (VAS-questionnaire) before test food ingestion | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed