euco EPS-continuous study

Not Applicable

• Conditions: Healthy volunteer

• Registration Number: JPRN-jRCTs031210218
• Lead Sponsor: Irie Junichiro

Brief Summary

This study suggested that the administration of leucosaccharide increased short-chain fatty acids and incretins production and could affect the regulation of glucose and energy metabolism in humans. Besides, the safety of the administration of leucosaccharide for a long period was confirmed. Further examinations are needed to establish a safer and more effective regime concerning dosage and duration.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Study Completion: 2022-01-08
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in fecal concentration of acetic acid from baseline to week 16