NCT05805488已完成不适用
Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The change of body weight (kg)
研究概览
简要总结
To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%.
- •History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol LDL-C > 130 mg/dL or triglyceride TG > 130 mg/dL), high-density lipoprotein cholesterol HDL-C < 40 mg/dL.
- •If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%).
- •Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.
排除标准
- •History of diabetic ketoacidosis.
- •Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months.
- •Known acute infectious illness within the past month with > 7 days of antibiotics.
- •Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month.
- •Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
- •History of any cancer in the past 5 years or still receiving cancer treatment.
- •Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis.
- •Patients with abnormal kidney function (eGFR < 30 mL/min/1.73 m^2).
- •Patients with a history of alcoholism.
- •Have participated in any other interventional clinical research within the last month.
- •Pregnant and lactating women.
- •Known history of allergy to the test substance.
- •Patients who are judged inappropriate by the trial host.
结局指标
主要结局
The change of body weight (kg)
时间窗: Week 0, week 12
The body weight was assessed by Body Composition Monitor
The change of body fat rate (%)
时间窗: Week 0, week 12
The body fat rate was assessed by Body Composition Monitor
The change of BMI (kg/m^2)
时间窗: Week 0, week 12
The BMI was assessed by Body Composition Monitor
次要结局
- The change of HDL-C(Week 0, week 12)
- The change of blood glucose(Week 0, week 12)
- The change of HbA1c(Week 0, week 12)
- The change of Matrix metalloproteinase (MMP)(Week 0, week 12)
- The change of alanine aminotransferase(Week 0, week 12)
- The change of blood urea nitrogen (BUN)(Week 0, week 12)
- The change of triglyceride(Week 0, week 12)
- The change of insulin(Week 0, week 12)
- The change of total cholesterol(Week 0, week 12)
- The change of C-reactive protein(Week 0, week 12)
- The change of albumin(Week 0, week 12)
- The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)(Week 0, week 12)
- The change of aspartate aminotransferase(Week 0, week 12)
- The change of LDL-C(Week 0, week 12)
- The change of TNF-alpha(Week 0, week 12)
- The change of cyclooxygenase-2 (COX-2)(Week 0, week 12)
- The change of creatine(Week 0, week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human SubjectsObesityNCT03248414Seoul National University Bundang Hospital114
已完成
不适用
The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight ReductionOverweight and ObesityNCT06244186China Medical University Hospital36
已完成
不适用
A study on the effect of LAB (heat-killed) on Visceral Fat.oJPRN-UMIN000037620Kagome Co., Ltd.120
已完成
不适用
Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic AdultsHypercholesterolemiaNCT01353820Danone Research100
已完成
不适用
Study of the effect of Lactobacillus LB product on healthy volunteers' fecal microbiota compositioNL-OMON48365IZO food research30