臨床研究等提出・公開システム

Effects of continuous administration of Leucosaccharide on Gut environment and metabolic parameters in Obese subjects; randomized, placebo-controlled, double blinded trial

Leuco EPS GO study

20

<Leucosaccharide 5.0g intake group> [Age (year (SD))] 45.8 (9.2) [Sex (n)] male 6 / female 4 [Hight (cm (SD))] 161.6 (5.1) [Body weight (kg (SD))] 94.9 (18.5) <Placebo group> [Age (year (SD))] 48.5 (10.9) [Sex (n)] male 6 / female 4 [Hight (cm (SD))] 169.0 (10.0) [Body weight (kg (SD))] 97.5 (29.3)

2021/6/30 Protocol approved by certified review board 2021/8/2 First publication in jRCT 2021/8/31 First subject in 2021/11/2 Last subject in 2021/12/10 Last subject last visit 2022/10/4 Database lock 2022/12/28 Development of Statistical Analysis Report

<Leucosaccharide 5.0g intake group> [Death (n (%))] 0 (0.0) [Adverse event (n (%))] 0 (0.0) [Serious adverse event (n (%))] 0 (0.0) [Disease-or-the-like (n (%))] 0 (0.0) [Serious disease-or-the-like (n (%))] 0 (0.0) <Placebo group> [Death (n (%))] 0 (0.0) [Adverse event (n (%))] 0 (0.0) [Serious adverse event (n (%))] 0 (0.0) [Disease-or-the-like (n (%))] 0 (0.0) [Serious disease-or-the-like (n (%))] 0 (0.0)

The primary endpoint in this study, i.e., the percentage change in fecal concentration of acetic acid from baseline to week 4, did not differ significantly between the two groups. The fecal concentration of propionic acid, butyric acid, and the sum of short-chain fatty acids tended to increase in the leucosaccharide group in comparison to those in the placebo group. The percentage change in fecal concentration of propionic acid was significantly greater in the leucosaccharide group. In addition, the concentration of propionic acid in the blood significantly increased in the leucosaccharide group and the level of PYY, which is a hormone to suppress appetite, also significantly increased in the leucosaccharide group in comparison to those in the placebo group. Furthermore, we found no adverse events or abnormalities in clinical laboratory tests and vital signs in this study.

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.

Jan. 31, 2024

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031210219

Irie Junichiro

Keio University Hospital

35 Shinanomachi,Shinjuku-ku,Tokyo, JAPAN

j-irie@z8.keio.jp

Nakajima Yuya

Keio University Hospital

35 Shinanomachi,Shinjuku-ku,Tokyo, JAPAN

+81-3-5363-3797

yunakajima@keio.jp

Complete

Aug. 02, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Obesity

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.

Percent change in fecal concentration of acetic acid from baseline to week 4

<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

+81-3-5363-3503

June. 30, 2021

none