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

未提供0 个研究点目标入组 20 人开始时间: 2021年8月31日最近更新: 2024年1月31日

适应症

试验速览

暂无简介。

•Patients who meet all of the following criteria are included in this study:
•Patients aged 20 years or older and 65 years or younger at giving their consent
•Obese outpatients (BMI >=25 kg/m2) in Keio University Hospital
•Patients who did not change type, dose, and usage of medications within 12 weeks before giving their consent
•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:
•Patients with HbA1c of 10% of higher at giving their consent
•Patients with history of gastrointestinal surgery, and who are instructed to restrict the dietary constituent
•Patients with gastrointestinal diseases, and who are instructed to restrict the dietary constituent
•Patients with malignant neoplasm
•Patients with severe infection
•Patients with uncontrolled psychiatric disorder
•Patients who took antimicrobial agents within 4 weeks before giving their consent
•Patients with secondary obesity
•Patients with diagnosis of apparent hepatic cirrhosis
•Patients with renal failure (serum creatinine level is 2.0 mg/dL or higher at giving their consent)
•Patients who took alpha-glucosidase inhibitor within 4 weeks before giving their consent
•Patients with history of uncontrolled allergy to foods or drugs
•Patients who are pregnant, possibly pregnant, within 90 days after delivery, or during breastfeeding
•Patients who cannot provide written consent form, or who cannot understand the summary and the purpose of the study
•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

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

Change in blood glucose-dependent insulinotropic polypeptide (GIP) (total, active)(baseline to week 4)
Percent change in fecal concentration of short-chain fatty acids(baseline to week 4)
Change in body weight, waist circumference, BMI, and blood pressure(baseline to week 4)
Change in blood test biomarkers(baseline to week 4)
Change in urine test biomarkers(baseline to week 4)

发起方

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