eucosaccharide EPS study
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-jRCTs031190088
- Lead Sponsor
- Irie Junichiro
- Brief Summary
The effect of supression of plasma glucose by administration of leucosaccharide was not demonstrated in this study. - Since this study suggested that GIP may increase by leucosaccharide administration, it was expected that leucosaccharide administration to the subjects whose glucose metabolism function was lowered improve the glycemic control. - This study confirmed the safety of single administration of leucosaccharide to healthy subject.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of plasma glucose from baseline to 120 min after food intake
- Secondary Outcome Measures
Name Time Method Dose-dependency of change of plasma glucose from baseline to 120 min after food intake<br>Change of plasma glucose from baseline to 15, 30, 45, 60, and 90 min after food intake<br>Ratio of area under the curve of plasma glucose during 0 to 120 min of food challenge test (leucosaccharide administration group / placebo group)<br>Change of blood test biomarkers from baseline to 15, 30, 45, 60, 90, and 120 min after food intake<br>Concentration of short-chain fatty acid in feces before and after food challenge test