Healthy volunteer
Conditions
Interventions
The study food in this study is the leucosaccharide-containing food. The form of the study food is white powder, packed in aluminium foil. One package of the study food includes 0g (placebo), 0.5g, 2.
Sponsors
Irie Junichiro
Itoh Hiroshi
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 at giving their consent 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 2 year before giving their consent, 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 with other conditions 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 |
|---|---|
| Percent change in fecal concentration of acetic acid from baseline to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood glucose-dependent insulinotropic polypeptide (GIP) (total, active) from baseline to week 16 - Percent change in fecal concentration of short-chain fatty acids (acetic acid, 3-hydroxybutyric acid, propionic acid, butyric acid, and sum of them) from baseline to week 4, 8, 12, and 16, from week 4 to week 8, 12, and 16, from week 8 to week 12 and 16, and from week 12 to week 16, except the primary endpoint - Change in blood GIP (total, active) from baseline to week 4, 8, and 12 - Change in plasma glucose from before the meal tolerance test to at 120 min of meal tolerance test at baseline and week 16, and the difference of them between the observation points - Ratio of area under the curve of plasma glucose during 0 to 120 min of meal tolerance test (after leucosaccharide administration (week 16) / before placebo administration (baseline)) - Change in blood test biomarkers from baseline to week 4, 8, 12, and 16 - Change in urine test biomarkers from baseline to week 4, 8, 12, and 16 | — |
Contacts
Public ContactYuya Nakajima
Keio University Hospital
Outcome results
None listed