Leuco EPS GO study

JRCT ID: jRCTs031210219

Registered date:02/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 31/08/2021
• Target sample size: 20
• 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), or 5.0g of leucosaccharide, and starch to adjust total weight to 5g. Subjects orally ingest the study foods with swallowing aid jelly.
After giving the written consent, the eligible subjects are randomly assigned into placebo group or leucosaccharide 5.0g group by permuted block method. The study subjects ingest the assigned study food once daily for 4 weeks +/- 2 week.
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 4

Secondary Outcome

<Important secondary endpoint>
Change in blood glucose-dependent insulinotropic polypeptide (GIP) (total, active) from baseline to week 4

<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 except the primary endpoint
- Change in body weight, waist circumference, BMI, and blood pressure from baseline to week 4
- Change in blood test biomarkers from baseline to week 4
- Change in urine test biomarkers from baseline to week 4

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

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