Healthy volunteer
Conditions
Interventions
[Placebo group]
Subjects orally ingest placebo (5.0g of starch) with swallowing aid jelly within about 1 min once, and take food challenge test and microbiome test.
[leucosaccharide 0.5g administratio
Sponsors
Irie Junichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers without any clinically diagnosed diseases, who meet all of the following criteria, are included in the study. 1) male and female aged 20 years or older and 65 years or younger 2) subjects who provide their written consent form to participate in the study after full explanation and enough understanding of the study 3) subjects who had a medical examination within 1 year, and who were not diagnosed with apparent glucose metabolism disorder (fasting plasma glucose of 126 mg/dl or higher, or casual plasma glucose of 200 mg/dl or higher) at that time
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are excluded from the study. 1) subjects who are treated for clinically diagnosed diseases 2) subjects with malignant neoplasm 3) subjects with severe infection 4) subjects with uncontrolled psychiatric disorder 5) subjects with history of uncontrolled allergy to foods or drugs 6) subjects who are pregnant, possibly pregnant, within 90 days after delivery, or during breastfeeding 7) subjects who cannot provide written consent form, or who cannot understand the summary and the purpose of the study 8) subjects who are considered to be unsuitable for participation in the study by the responsible investigator or investigators due to the safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of plasma glucose from baseline to 120 min after food intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-dependency of change of plasma glucose from baseline to 120 min after food intake Change of plasma glucose from baseline to 15, 30, 45, 60, and 90 min after food intake Ratio of area under the curve of plasma glucose during 0 to 120 min of food challenge test (leucosaccharide administration group / placebo group) Change of blood test biomarkers from baseline to 15, 30, 45, 60, 90, and 120 min after food intake Concentration of short-chain fatty acid in feces before and after food challenge test | — |
Contacts
Public ContactYuya Nakajima
Keio University Hospital
Outcome results
None listed