Healthy adults
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy male adults aged from 20 y to 64 y (2) Subjects with fasting glucose from 100 to 125 mg/dl (3) Subjects can consume test foods, and record life diaries and meal diaries (4) Subjects who have given written informed consent prior to study
Exclusion criteria
Exclusion criteria: (1) Subjects diagnosed with diabetes, or taking drugs related diabetes (2) Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease (3) Subjects who have symptom of liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases (4) Subjects who have a history of resection of gastrointestinal tract, excluding cecal resection surgery (5) Heavy drinker (over 30g alcohol per day) (6) Subjects who have donated over 200 ml of blood within the last one month prior to the current study or over 400 ml of blood within the last three months prior to the study (7) Subjects who have severe anemia (Hb <=7g/dL) (8) Subjects who have food allergies for test foods (9) Subjects who are planned to participate in other clinical study during current study (10) Subjects who are judged to be inappropriate for the study by the medical doctor or principal investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin, glucagon, 1.5-AG, glycol-albumin, gastrointestinal hormone, triglyceride, apo B48, ketone body, body weight, body fat ratio, appetite (questionnaire) | — |
Countries
Japan
Contacts
TES Holdings Co., Ltd. Administrative Department of Clinical Trials