Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Changes in body weight
研究概览
简要总结
Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.
详细描述
The study will include obese patients (body mass index; BMI ≥ 37.5 kg/m2 or BMI ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at Ramathibodi Hospital, Thailand. The VLCD group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo LRYGB or LSG. Study participants in both groups will be matched according to their age, sex, body mass index (BMI) and diabetic status. Body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 15-65 years
- •Male or female
- •Body mass index ≥ 32.5 kg/m2 with obesity related co-morbidity
- •Body mass index ≥ 37.5 kg/m2 with or without an obesity related co-morbidity
排除标准
- •End stage disease such as cancer, cirrhosis Child-Pugh C, critical/acute illness
- •Type 1 diabetes mellitus
- •Recent eGFR < 30 ml/min/1.73 m2
- •Weight loss ≥ 5% in the previous 3 months
- •Use of antibiotics in the previous 1 month
- •Use of probiotic or prebiotic supplement in form of tablet or sachet in the previous 14 days
- •Current treatment with anti-obesity drugs
- •Pregnancy or breast feeding
- •Substance abuse
- •Uncontrolled psychiatric disorder and eating order
- •History of allergy to any components in meal replacement product or whey protein product
- •Unable to give informed consent
结局指标
主要结局
Changes in body weight
时间窗: From baseline to 12 weeks
Weight in kg
次要结局
- Triglyceride(From baseline to 12 weeks)
- Body Composition(From baseline to 12 weeks)
- Gut microbiota pattern(From baseline to 12 weeks)
- Liver steatosis(From baseline to 12 weeks)
- Fasting insulin(From baseline to 12 weeks)
- Insulin resistance(From baseline to 12 weeks)
- Liver stiffness(From baseline to 12 weeks)
- Fasting plasma glucose(From baseline to 12 weeks)
- Hemoglobin A1c(From baseline to 12 weeks)
- Depression(From baseline to 12 weeks)
- Blood pressure(From baseline to 12 weeks)
- HDL-cholesterol(From baseline to 12 weeks)
- Health-related quality of life(From baseline to 12 weeks)
- Total cholesterol(From baseline to 12 weeks)
- LDL-cholesterol(From baseline to 12 weeks)
研究者
Chanawit Saiyalam
Faculty of Medicine Ramathibodi Hospital Mahidol University
Mahidol University