Leuco EPS-continuous study

JRCT ID: jRCTs031210218

Registered date:02/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 30/08/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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, 2.5g, or 5.0g of leucosaccharide, and starch to adjust t
otal weight to 5g. Subjects orally ingest the study foods with swallowing aid jelly.
After giving the written consent, the eligible subjects take fecal test and meal tolerance test. The study subjects then ingest placebo and the leucosaccharide-containing study food (in the order of 0.5g, 2.5g, and 5.0g) once daily for 4 weeks +/- 1 week each. Fecal tests are conducted at the end of each dose of the study foods. The meal tolerance test is also conducted at the end of 5.0g leucosaccharide-containing study food ingestion.
The study food in this study is treated as unapproved medical agent, defined in the Clinical Trial Act, to be investigated in this study.

Outcome(s)

• Primary Outcome: Percent change in fecal concentration of acetic acid from baseline to week 16

Secondary Outcome

<Important secondary endpoint>
Change in blood glucose-dependent insulinotropic polypeptide (GIP) (total, active) from baseline to week 16

<secondary endpoints>
- 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Irie Junichiro
• Secondary Sponsor: Itoh Hiroshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development