Healthy adults
Conditions
Interventions
Take the test food 1 containing Glucolacto-oligosaccharides within 5 min.
Take the placebo food 1 containing sucrose within 5 min.
Take the test food 2 containing Glucolacto-oligosaccharides within 5
Sponsors
Meiji Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who are Japanese men aged 20 to below 65 years at the time of consent acquisition. 2. Subjects whose BMI are 18.5 or more and less than 25. 3. Subjects whose fasting blood glucose level are less than 126 mg/dL on SCR blood test. 4. Subjects who can obtaining time-dependently blood sampling. 5. Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who have severe or progressive diseases, such as cardiac-, hepatic-, kidney-, heart-, lung- and digestive- diseases, diabetes mellitus, rheumatoid arthritis, neurological disease, psychiatric disorders, endocrine disease, and other diseases. 2. Subjects who are taking medications for diabetes mellitus. 3. Subjects who have food allergy. 4. Subjects who are aware of lactose intolerance. 5. Subjects with a history of stomach or small intestine resection (excluding polypectomy and minor surgery). 6. Subjects who are heavy drinkers with an average daily intake of over 60 g in terms of pure alcohol. 7. Subjects with Tmax of postprandial blood glucose levels at 90min. 8. Subjects who are current smoker. 9. Subjects who fast or miss a meal (4 or more days a week) on a regular basis. 10. Subjects with carbohydrate-restricted diet (1 or more days a week). 11. Subjects who donate blood more than 200 mL of blood and/or blood components within 1 month prior to the date of obtaining informed consent. 12. Subjects who have participated in other clinical trials within 1 month prior to the date of obtaining informed consent (excluding observation study). 13. Subjects who are judged unsuitable for this study by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose levels (incremental AUC, Cmax, delta Cmax, Tmax, and change of blood glucose and delta postprandial blood glucose) Serum insulin levels (incremental AUC, Cmax, delta Cmax and change of insulin secretion and delta value) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed