Healthy adults
Conditions
Sponsors
Meiji Co., Ltd.
CPCC Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy men range in age from 30 to 60 at the time of informed consent. 2.Subjects with a BMI of 18.5 or more and less than 25. 3.Subjects who eat three meals a day (allowing up to 3 days of skipping meals per week). 4.Subjects whose defecation frequency are more than 3 times a week. 5.Subjects who are capable of undergoing serial blood sampling. 6.Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Exclusion criteria
Exclusion criteria: 1. Subjects with food allergies. 2. Subjects who suffer from serious disorders of liver, kidney, heart, lung, digestive organs (including gastric resection), diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases. 3. Subjects with a history of resection of the stomach, small intestine, or large intestine (including appendectomy or colonoscopy procedures within one year prior to the consent date). 4. Heavy drinkers (weekly average of 30 g / day or more of pure alcohol). 5. Smoker. 6. Subjects who regularly take supplements and health foods for intestinal function or containing prebiotics (e.g. Oligosaccharide, dietary fiber) , defined as usage at least three days a week continuously for two weeks or more. 7. Subjects who habitually practice carbohydrate restriction (such as Low-Carb, Lo-Carb diets) at least once a week. 8. Subjects using blood glucose-lowering medications, including insulin. 9. Subjects currently taking oral medication for allergic rhinitis or who may take such medication during the study period (excluding those who only use nasal sprays or eye drops). 10. Subjects who donated more than 200ml blood within the past 1 month. 11. Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period. 12. Subjects with fasting blood glucose levels of 126 mg/dL or higher. 13. Shift workers, night workers, or individuals with irregular sleep cycles. 14. Subjects who determine ineligible by the principal investigator or the co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood insulin level, Breath hydrogen concentrations, VAS (Hunger, Sleepiness, Bloating, Stomach Rumbling) | — |
Countries
Japan
Contacts
Public ContactKakeru Masada
Meiji Co., Ltd. R&D Division
Outcome results
None listed