Inflammation, Weight Loss
Conditions
Keywords
microbiota, obesity
Brief summary
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
Detailed description
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).
Interventions
OTHERDiet
Very low calorie ketogenic diet followed by low calorie diet
DIETARY_SUPPLEMENTSynbiotic1
B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber
DIETARY_SUPPLEMENTSynbiotic2
B. animalis subsp. lactis and prebiotics fiber
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* body mass index ≥ 30 kg/m2 * stable body weight in the previous 3 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes produced in the composition and diversity of gut microbiota by the use of synbiotics during a dietary intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in intestinal permeability markers produced by the use of synbiotics during a dietary intervention | At baseline and at 4 months | Blood samples were collected at baseline and at the end of study. Plasma Zonulin levels were measured by enzyme linked immunosorbent assay |
| Changes in intestinal inflammation markers produced by the use of synbiotics during a dietary intervention | At baseline and at 4 months | Blood samples were collected at baseline and at the end of study. Plasma C-reactive protein levels were measured by enzyme linked immunosorbent assay |
| Changes in microbial translocation markers produced by the use of synbiotics during a dietary intervention | At baseline and at 4 months | Blood samples were collected at baseline and at the end of study. Plasma lipopolysaccharide binding protein levels were measured by enzyme linked immunosorbent assay |
Countries
Spain
Outcome results
None listed