JPRN-jRCTs031210219已完成未知
Effects of continuous administration of Leucosaccharide on Gut environment and metabolic parameters in Obese subjects; randomized, placebo-controlled, double blinded trial
Irie Junichiro0 个研究点目标入组 20 人开始时间: 2021年8月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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