Effects of Very-low Ketogenic Diet in Gut Microbiota and Its Restitution With the Use of Synbiotic Supplementation in Patients Following a Weight Loss Programme (Pronokal Method)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention
研究概览
简要总结
The present study aimed to investigate the changes produced in gut microbiota by a very-low-calorie-ketogenic diet followed by a low calorie diet, whether the use of synbiotics is able to modulate gut microbiota diversity and composition and its association with gut permeability and inflammation
详细描述
All participants followed a very-low-calorie ketogenic diet according to a commercial weight loss program (Pronokal method), which includes lifestyle and behavioural modification support. This method is based on high-biological-value protein preparations which contained 15 g protein, 4 g carbohydrates, 3 g fat and 50 mg docosahexaenoic acid, and provided 90-110 kcal. The study was divided in two phases. The first phase consists of a very-low-calorie ketogenic diet (600-800 kcal/day), low in carbohydrates and lipids. Throughout this ketogenic phase, supplements of vitamins and minerals such as K, Na, Mg, Ca and omega-3 fatty acids were provided. In this study the ketogenic step was maintained for 2 months. Then, the patients started a low-calorie diet (800-1500 kcal/day) which lasted two months.
During the first phase consisting of a very-low-calorie ketogenic diet, subjects were randomly divided into two groups, the treatment group who received synbiotic supplementation as capsules, a complex of B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber (synbiotic 1) and the control group who received a placebo. During the second phase consisting of a low-calorie diet, the treatment group received synbiotic supplementation as capsules consisting of B. animalis subsp. lactis and prebiotics fiber (synbiotic 2) (synbiotic1 + synbiotic 2 group), while the control group was divided into two groups: one continued receiving a placebo (control group) whilst the other group received synbiotic 2 (placebo + synbiotic2 group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index ≥ 30 kg/m2
- •stable body weight in the previous 3 months
排除标准
- •Diabetes mellitus
- •Obesity induced by endocrine disorders or by drugs
- •Gastrointestinal disorders
- •Use of antibiotics, probiotic or prebiotic agent which could modify microbiota in the previous 3 months
- •Severe depression or any other psychiatric disease
- •Abuse of narcotics or alcohol
- •Severe hepatic insufficiency
- •Any type of renal insufficiency or gout episodes
- •Neoplasia
- •Previous events of cardiovascular or cerebrovascular disease
- •Renal lithiasis
- •Uncontrolled hypertension and hydroelectrolytic alterations
- •Females with child-bearing potential, who were pregnant, breast-feeding, intending to become pregnant
研究组 & 干预措施
Placebo
Very low calorie ketogenic diet followed by low calorie diet
干预措施: Diet (Other)
placebo +synbiotic2
Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
干预措施: Synbiotic2 (Dietary Supplement)
Synbiotic1+synbiotic2
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
干预措施: Diet (Other)
Synbiotic1+synbiotic2
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
干预措施: Synbiotic1 (Dietary Supplement)
Synbiotic1+synbiotic2
Very low calorie ketogenic diet supplemented with synbiotic 1 followed by low calorie diet supplemented with synbiotic2
干预措施: Synbiotic2 (Dietary Supplement)
placebo +synbiotic2
Very low calorie ketogenic diet supplemented with placebo followed by low calorie diet supplemented with synbiotic2
干预措施: Diet (Other)
结局指标
主要结局
Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention
时间窗: At baseline and at 4 months
Fecal samples were collected at baseline and at the end of dietary intervention. Fecal DNA was extracted and Gut microbiota analysis was achieved by using high-throughput sequencing
次要结局
- Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention(At baseline and at 4 months)
- Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention(At baseline and at 4 months)
- Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention(At baseline and at 4 months)