The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
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
- Body weight
研究概览
简要总结
To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.
详细描述
The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.
A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
- •Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol > 130 mg/dL or triglycerides > 130 mg/dL), high-density lipoprotein cholesterol < 40 mg/dL
- •If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
- •Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form
排除标准
- •History of diabetic ketoacidosis
- •Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
- •Occurrence of acute infectious diseases within the last month and antibiotic use for > 7 days
- •Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
- •Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
- •History of any cancer or undergoing cancer treatment in the past 5 years
- •Abnormal liver function (GOT or GPT greater than 3 times the normal upper limit) or liver cirrhosis
- •Impaired kidney function (eGFR < 30 mL/min/1.73 m2)
- •History of alcohol abuse
- •Participation in any other interventional clinical research within the last month
- •Pregnant and breastfeeding women
- •History of allergy to the investigational product
- •Participants deemed unsuitable for inclusion by the principal investigator
研究组 & 干预措施
Probiotics
Take one packet (6 grams) of powder orally once daily. The probiotics contain fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, silicon dioxide, and Lactobacillus delbrueckii subsp. Bulgaricus.
干预措施: Probiotics (Dietary Supplement)
Placebo
Placebo contains fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, and silicon dioxide.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 84 days
Comparing the changes between Day 0 and Day 84
Body fat
时间窗: 84 days
Comparing the changes between Day 0 and Day 84
BMI
时间窗: 84 days
Comparing the changes between Day 0 and Day 84
次要结局
- Changes in glycated hemoglobin(84 days)
- CRE, BUN and GLU-AC (mg/dL) in Blood composition(84 days)
- Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition(84 days)
- ALT and AST (U/L) in Blood composition(84 days)