euco EPS GO study

Not Applicable

• Conditions: Obesity

• Registration Number: JPRN-jRCTs031210219
• Lead Sponsor: Irie Junichiro

Brief Summary

The results of the study showed the administration of leucosaccharide increased the short-chain fatty acids in individuals with obesity. Besides, the safety of leucosaccharide in the subjects with obesity was confirmed. The leucosaccharide could be an effective treatment for type 2 diabetes and obesity. Further investigations are required to establish a safer and more effective way to administer leucosaccharide to individuals with obesity in terms of dosage and duration.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Study Completion: 2021-12-10
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1) Patients aged 20 years or older and 65 years or younger at giving their consent
2) Obese outpatients (BMI >=25 kg/m2) in Keio University Hospital
3) Patients who did not change type, dose, and usage of medications within 12 weeks before giving their consent
4) Patients who provide their written consent form to participate in the study after full explanation and enough understanding of the study

Exclusion Criteria

Patients who meet any of the following criteria are excluded from the study:
1) Patients with HbA1c of 10% of higher at giving their consent
2) Patients with history of gastrointestinal surgery, and who are instructed to restrict the dietary constituent
3) Patients with gastrointestinal diseases, and who are instructed to restrict the dietary constituent
4) Patients with malignant neoplasm
5) Patients with severe infection
6) Patients with uncontrolled psychiatric disorder
7) Patients who took antimicrobial agents within 4 weeks before giving their consent
8) Patients with secondary obesity
9) Patients with diagnosis of apparent hepatic cirrhosis
10) Patients with renal failure (serum creatinine level is 2.0 mg/dL or higher at giving their consent)
11) Patients who took alpha-glucosidase inhibitor within 4 weeks before giving their consent
12) Patients with history of uncontrolled allergy to foods or drugs
13) Patients who are pregnant, possibly pregnant, within 90 days after delivery, or during breastfeeding
14) Patients who cannot provide written consent form, or who cannot understand the summary and the purpose of the study
15) Patients 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 4

Secondary Outcome Measures

Name	Time	Method
<Important secondary endpoint><br>Change in blood glucose-dependent insulinotropic polypeptide (GIP) (total, active) from baseline to week 4<br><br><secondary endpoints><br>- 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 except the primary endpoint<br>- Change in body weight, waist circumference, BMI, and blood pressure from baseline to week 4<br>- Change in blood test biomarkers from baseline to week 4<br>- Change in urine test biomarkers from baseline to week 4