Inflammation Clinical Trial
Official title:
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)
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
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).
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